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Trazodone Hydrochloride
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Serotonin Reuptake Inhibitor [EPC] | EPC | All 51 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 205253-001 | TRAZODONE HYDROCHLORIDE | TABLET | TRAZODONE HYDROCHLORIDE | Prescription | AB | ||
| 205253-002 | TRAZODONE HYDROCHLORIDE | TABLET | TRAZODONE HYDROCHLORIDE | Prescription | AB | ||
| 205253-003 | TRAZODONE HYDROCHLORIDE | TABLET | TRAZODONE HYDROCHLORIDE | Prescription | AB | ||
| 205253-004 | TRAZODONE HYDROCHLORIDE | TABLET | TRAZODONE HYDROCHLORIDE | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 24 | Labeling | Approved | June 24, 2025 | Standard |
| Supplement | 21 | Manufacturing (CMC) | Tentative approval | February 29, 2024 | Unknown |
| Supplement | 18 | Labeling | Approved | October 18, 2022 | Standard |
| Supplement | 8 | Labeling | Approved | October 30, 2020 | Standard |
| Supplement | 4 | Labeling | Approved | April 20, 2020 | Standard |
| Original application | 1 | Approved | October 10, 2017 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260730). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING: SUICIDAL THOUGHTS and BEHAVIORS See full prescribing information for complete boxed warning. • Antidepresants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 ) • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) • Trazodone hydrochloride tablets are not approved for use in pediatric patients ( 8.4 ) WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies . Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . Trazodone hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] .
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE Trazodone hydrochloride tablets, USP are a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ). Trazodone hydrochloride tablets, USP are indicated for the treatment of major depressive disorder (MDD) in adults.
Dosage and Administration
openFDA Drug Labeling2 DOSAGE AND ADMINISTRATION • Starting dose: 150 mg in divided doses daily. May be increased by 50 mg per day every three to four days. Maximum dose: 400 mg per day in divided doses ( 2 ). • Trazodone hydrochloride tablets should be taken shortly after a meal or light snack ( 2 ). • Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed( 2 ). • When discontinued, gradual dose reduction is recommended ( 2 ). 2.1 Dose Selection An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response. 2.2 Important Administration Instructions Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line. Trazodone hydrochloride tablets should be taken shortly after a meal or light snack. 2.3 Screen for Bipolar Disorder Prior to Starting Trazodone Hydrochloride Tablets Prior to initiating treatment with trazodone hydrochloride tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( 5.7 )]. 2.4 Switching to or from Monoamine Oxidase Inhibitor Antidepressant At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of trazodone hydrochloride tablets. In addition, at least 14 days must elapse after stopping trazodone hydrochloride tablets before starting an MAOI antidepressant [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 )]. 2.5 Dosage Recommendations for Concomitant Use with Strong CYP3A4 Inhibitors or Inducers Coadministration with Strong CYP3A4 Inhibitors Consider reducing trazodone hydrochloride tablets dose based on tolerability when trazodone hydrochloride tablets are coadministered with a strong CYP3A4 inhibitor [see Drug Interactions ( 7.1 )]. Coadministration with Strong CYP3A4 Inducers Consider increasing trazodone hydrochloride tablets dose based on therapeutic response when trazodone hydrochloride tablets are coadministered with a strong CYP3A4 inducer [see Drug Interactions ( 7.1 )]. 2.6 Discontinuation of Treatment with Trazodone Hydrochloride Tablets Adverse reactions may occur upon discontinuation of trazodone hydrochloride tablets [See Warnings and Precautions ( 5.8 )]. Gradually reduce the dosage rather than stopping trazodone hydrochloride tablets abruptly whenever possible.
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS • Scored tablets of 50 mg, 100 mg, 150 mg and 300 mg ( 3 ). Trazodone hydrochloride tablets, USP are available in the following strengths: Trazodone hydrochloride tablets USP, 50 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '05' on lower side of bisect. Trazodone hydrochloride tablets USP, 100 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '06' on lower side of bisect. Trazodone hydrochloride tablets USP, 150 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '07' on other bisect segments. Trazodone hydrochloride tablets USP, 300 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '08' on other bisect segment.
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS None ( 4 ). • Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 ). Trazodone hydrochloride tablets are contraindicated in: • Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 )].
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue trazodone and initiate supportive treatment ( 5.2 ). • Cardiac Arrhythmias: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval ( 5.3 ) • Orthostatic Hypotension and Syncope: Warn patients of risk and symptoms of hypotension ( 5.4 ). • Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.5 ). • Priapism: Cases of painful and prolonged penile erections and priapism have been reported. Immediate medical attention should be sought if signs and symptoms of prolonged penile erections or priapism are observed ( 5.6 ). • Activation of Mania or Hypomania: Screen for bipolar disorder and monitor for mania or hypomania ( 5.7 ). • Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Advise patients to use caution when operating machinery ( 5.9 ). • Angle-Closure Glaucoma: Avoid use of antidepressants, including trazodone, in patients with untreated anatomically narrow angles. ( 5.10 ). 5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1. No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. Table 1 Risk Differences of the Number of Cases of Suicidal Thoughts or Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric and Adult Patients Age Range (years) Drug-Placebo Difference in Number of Patients of Suicidal Thoughts or Behaviors per 1,000 Patients Treated Increases Compared to Placebo < 18 14 additional patients 18 to 24 5 additional patients Decreases Compared to Placebo 25 to 64 1 fewer patient ≥ 65 6 fewer patients It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing trazodone, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors. 5.2 Serotonin Syndrome Serotonin-norepinephrine reuptake inhibitors (SNRIs) and SSRIs, including trazodone, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin, i.e., MAOIs [see Contraindications ( 4 ), Drug Interactions ( 7.1 )] . Serotonin syndrome can also occur when …
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behavior in Children, Adolescents and Young Adults [see Boxed Warning and Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Cardiac Arrythmias ( see Warnings and Precautions ( 5.3 )] Orthostatic Hypotension and Syncope [see Warnings and Precautions ( 5.4 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.5 )] Priapism [see Warnings and Precautions ( 5.6 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.7 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.8 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.9 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.10 )] Hyponatremia [see Warnings and Precautions ( 5.11 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Table 2 Common Adverse Reactions Occurring in ≥ 2% of Trazodone-treated Patients and Greater than the Rate of Placebo-Treated Patients as Observed in Controlled Clinical Studies Inpatients Outpatients Trazodone Placebo Trazodone Placebo 142 95 157 158 Allergic Skin Condition/Edema 3% 1% 7% 1% Autonomic Blurred Vision 6% 4% 15% 4% Constipation 7% 4% 8% 6% Dry Mouth 15% 8% 34% 20% Cardiovascular Hypertension 20% 1% 1% * Hypotension 7% 1% 4% 0 Syncope 3% 2% 5% 1% CNS Confusion 5% 0 6% 8% Decreased Concentration 3% 2% 1% 0 Disorientation 2% 0 * 0 Dizziness/Light-Headedness 20% 5% 28% 15% Drowsiness 24% 6% 41% 20% Fatigue 11% 4% 6% 3% Headache 10% 5% 20% 16% Nervousness 15% 11% 6% 8% Gastrointestinal Abdominal/Gastric Disorder 4% 4% 6% 4% Diarrhea 0 1% 5% 1% Nausea/Vomiting 10% 1% 13% 10% Musculoskeletal Aches/Pains 6% 3% 5% 3% Neurological Incoordination 5% 0 2% * Tremors 3% 1% 5% 4% Other Eyes Red/Tired/Itching 3% 0 0 0 Head Full-Heavy 3% 0 0 0 Malaise 3% 0 0 0 Nasal/Sinus Congestion 3% 0 6% 3% Weight Gain 1% 0 5% 2% Weight Loss * 3% 6% 3% Other adverse reactions occurring at an incidence of <2% with the use of trazodone hydrochloride in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired memory, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, paresthesia, retrograde ejaculation, shortness of breath, and tachycardia/palpitations. Occasional sinus bradycardia has occurred in long-term studies. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of trazodone. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders: hemolytic anemia, leukocytosis Cardiac disorders: cardiospasm, congestive heart failure, conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, ventricular ectopic activity, including ventricular tachycardia and QT prolongation. Prolonged QT interval, torsade de pointes, and ventricular tachycardia have been reported at doses of 100 mg per day or less [see Warnings and Precautions ( 5.3 )]. Endocrine disorders: inappropriat …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS CNS Depressants: Trazodone hydrochloride may enhance effects of alcohol, barbiturates, or other CNS depressants ( 7 ). CYP3A4 Inhibitors: Consider trazodone hydrochloride tablets dose reduction based on tolerability ( 2.5 , 7 ). CYP3A4 Inducers: Increase in trazodone hydrochloride tablets dosage may be necessary ( 2.5 , 7 ). Digoxin or Phenytoin: Monitor for increased digoxin or phenytoin serum levels ( 7 ). Warfarin: Monitor for increased or decreased prothrombin time ( 7 ). 7.1 Drugs Having Clinically Important Interactions with Trazodone Hydrochloride Table 3: Clinically Important Drug Interactions with Trazodone Hydrochloride Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of MAOIs and serotonergic drugs including trazodone hydrochloride increases the risk of serotonin syndrome. Intervention: Trazodone hydrochloride is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Contraindications ( 4 ), Dosage and Administration ( 2.3 , 2.4 ), and Warnings and Precautions ( 5.2 )]. Examples: isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine Other Serotonergic Drugs Clinical Impact: The concomitant use of serotonergic drugs including trazodone hydrochloride and other serotonergic drugs increases the risk of serotonin syndrome. Intervention: Monitor patients for signs and symptoms of serotonin syndrome, particularly during trazodone hydrochloride initiation. If serotonin syndrome occurs, consider discontinuation of trazodone hydrochloride and/or concomitant serotonergic drugs [see Warnings and Precautions ( 5.2 )]. Examples: triptans, antidepressants (tricyclic and serotonin uptake inhibitors), fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort Antiplatelet Agents and Anticoagulants Clinical Impact: Serotonin release by platelets plays an important role in hemostasis. The concurrent use of an antiplatelet agent or anticoagulant with trazodone hydrochloride may potentiate the risk of bleeding. Intervention: Inform patients of the increased risk of bleeding with the concomitant use of trazodone hydrochloride and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating or discontinuing trazodone hydrochloride [see Warnings and Precautions ( 5.5 )]. Examples: warfarin, rivaroxaban, dabigatran, clopidogrel Strong CYP3A4 Inhibitors Clinical Impact: The concomitant use of trazodone hydrochloride and strong CYP3A4 inhibitors increased the exposure of trazodone compared to the use of trazodone hydrochloride alone. Intervention: If trazodone hydrochloride is used with a potent CYP3A4 inhibitor, the risk of adverse reactions, including cardiac arrhythmias, may be increased and a lower dose of trazodone hydrochloride should be considered [see Dosage and Administration ( 2.5 ), Warnings and Precautions ( 5.3 )]. Examples: itraconazole, ketoconazole, clarithromycin, indinavir Strong CYP3A4 Inducers Clinical Impact: The concomitant use of trazodone hydrochloride and strong CYP3A4 inducers decreased the exposure of trazodone compared to the use of trazodone hydrochloride alone. Intervention: Patients should be closely monitored to see if there is a need for an increased dose of trazodone hydrochloride when taking CYP3A4 inducers [see Dosage and Administration ( 2.5 )]. Examples: rifampin, carbamazepine, phenytoin, St. John’s wort Digoxin and Phenytoin Clinical Impact: Digoxin and phenytoin are narrow therapeutic index drugs. Concomitant use of trazodone hydrochloride can increase digoxin or phenytoin concentrations. Intervention: Measure serum digoxin or phenytoin concentrations before initiating concomitant use of trazodone hydrochloride. Continue monitoring and reduce digoxin or phenytoin dose as necessary. Examples: digoxin, phenytoin Central Nervous System (CNS) Depressants Clinical Impact: Trazodone hydrochloride may …
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/ pregnancyregistry/ antidepressants/ Risk Summary Published prospective cohort studies, case series, and case reports over several decades with trazodone hydrochloride tablets use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 times to 11 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m 2 basis. There was also an increase in congenital anomalies in the rabbit at approximately 7.3 times to 22 times the MRHD on a mg/m 2 basis (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryofetal risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression that women who continued antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Data Human Data While available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with trazodone use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. All available studies have methodological limitations, including small sample size and inconsistent comparator groups. Animal Data No teratogenic effects were observed when trazodone was given to pregnant rats and rabbits during the period of organogenesis at oral doses up to 450 mg/kg/day. This dose is 11 times and 22 times, in rats and rabbits, respectively, the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m 2 basis. Increased fetal resorption and other adverse effects on the fetus in rats at 7.3 times to 11 times the MRHD and increase in congenital anomalies in rabbits at 7.3 times to 22 times the MRHD on a mg/m 2 basis were observed. No further details on these studies are available. 8.2 Lactation Risk Summary Data from published literature report the transfer of trazodone into human milk. There are no data on the effect of trazodone on milk production. Limited data from postmarketing reports have not identified and association of adverse effects on the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for trazodone hydrochloride tablets and any potential adverse effects on the breastfed child from trazodone hydrochloride tablets or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in the pediatric population have not been established. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [ see Boxed Warning, Warnings and Precautions ( 5.1 …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action The mechanism of trazodone's antidepressant action is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT 2 receptor antagonist and the net result of this action on serotonergic transmission and its role in trazodone's antidepressant effect is unknown.
Description
openFDA Drug Labeling11 DESCRIPTION Trazodone hydrochloride tablets, USP for oral administration contain trazodone hydrochloride, USP, a selective serotonin reuptake inhibitor and 5HT2 receptor antagonist. Trazodone hydrochloride is a triazolopyridine derivative designated as 1,2,4-Triazolo[4,3-a]pyridin-3(2H)-one, 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-, monohydrochloride. It is a white to off white, crystalline powder which is sparingly soluble in chloroform and in water. The structural formula is represented as follows: Molecular Formula: C 19 H 22 CIN 5 O • HCl Molecular Weight: 408.32 Each tablet, for oral administration, contains 50 mg, 100 mg, 150 mg or 300 mg of trazodone hydrochloride, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinised starch, sodium lauryl sulphate, sodium starch glycolate type A. FDA approved dissolution test specifications differ from USP. trazodone-structure
Overdosage
openFDA Drug Labeling10 OVERDOSAGE Death from overdose has occurred in patients ingesting trazodone hydrochloride tablets and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate). The most severe reactions reported to have occurred with overdose of trazodone hydrochloride tablets alone have been priapism, respiratory arrest, seizures, ECG changes, including QT prolongation and syndrome of inappropriate antidiuretic hormone secretion (SIADH). The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions. There is no specific antidote for trazodone hydrochloride overdose. In managing overdosage, consider the possibility of multiple drug involvement. For current information on the management of poisoning or overdose, contact a poison control center (1-800-222-1222 or www.poison.org ).
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING Trazodone Hydrochloride Tablets USP, 50 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '05' on lower side of bisect and are supplied as follows: NDC 68382-805-06 in bottle of 30 tablets with child-resistant closure NDC 68382-805-16 in bottle of 90 tablets with child-resistant closure NDC 68382-805-01 in bottle of 100 tablets NDC 68382-805-05 in bottle of 500 tablets NDC 68382-805-10 in bottle of 1,000 tablets NDC 68382-805-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Trazodone Hydrochloride Tablets USP, 100 mg are white to off-white, round-shape, biconvex beveled tablets, bisect on one side and plain on other side. The bisected side of tablet is debossed with '8' on upper side of bisect and '06' on lower side of bisect and are supplied as follows: NDC 68382-806-06 in bottle of 30 tablets with child-resistant closure NDC 68382-806-16 in bottle of 90 tablets with child-resistant closure NDC 68382-806-01 in bottle of 100 tablets NDC 68382-806-05 in bottle of 500 tablets NDC 68382-806-10 in bottle of 1,000 tablets NDC 68382-806-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Trazodone Hydrochloride Tablets USP, 150 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '07' on other bisect segments and are supplied as follows: NDC 68382-807-06 in bottle of 30 tablets with child-resistant closure NDC 68382-807-16 in bottle of 90 tablets with child-resistant closure NDC 68382-807-01 in bottle of 100 tablets NDC 68382-807-05 in bottle of 500 tablets NDC 68382-807-10 in bottle of 1,000 tablets NDC 68382-807-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Directions for using the correct score when breaking the tablet, please refer to the following: -For 50 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 75 mg, break the score down the middle of the tablet (one-half of a tablet). -For 100 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 150 mg, use the entire tablet. Trazodone Hydrochloride Tablets USP, 300 mg are white to off-white, oval-shape, flat faced beveled tablets having one full bisect and two trisect notches on one side and two trisects on other side. The full bisected side of tablet is debossed with '8' on one side of bisect and '08' on other bisect segment and are supplied as follows: NDC 68382-808-06 in bottle of 30 tablets with child-resistant closure NDC 68382-808-16 in bottle of 90 tablets with child-resistant closure NDC 68382-808-01 in bottle of 100 tablets NDC 68382-808-05 in bottle of 500 tablets NDC 68382-808-10 in bottle of 1,000 tablets NDC 68382-808-77 in unit-dose blister carton of 100 (10 x 10) unit-dose tablets Directions for using the correct score when breaking the tablet, please refer to the following: -For 100 mg, break the score on either the left or right side of the tablet (one-third of a tablet). -For 150 mg, break the score down the middle of the tablet (one-half of a tablet). -For 200 mg, break the score on either the left or right side of the tablet (two-thirds of a tablet). -For 300 mg, use the entire tablet. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense with a child-resistant closure in a tight, light-resistant container. Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP Trazodone Hydrochloride Tablets USP
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: TRAZODONE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class II | September 9, 2026 | Teva Pharmaceuticals USA, Inc | Presence of Foreign Tablets/Capsules | Ongoing |
| Class II | February 11, 2026 | Granules Pharmaceuticals Inc. | Presence of Foreign Tablets/Capsules | Ongoing |
| Class III | January 7, 2026 | Zydus Pharmaceuticals (USA) Inc | Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. | Ongoing |
| Class II | June 2, 2021 | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Terminated |
| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-4283-0 | 50090-4283 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-4283-0) | April 26, 2019 |
| 50090-4283-2 | 50090-4283 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-4283-2) | April 26, 2019 |
| 50090-4283-3 | 50090-4283 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-4283-3) | April 26, 2019 |
| 50090-4825-2 | 50090-4825 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-4825-2) | January 3, 2020 |
| 50090-4825-4 | 50090-4825 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-4825-4) | January 3, 2020 |
| 50090-5218-0 | 50090-5218 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-5218-0) | October 6, 2020 |
| 50090-5218-1 | 50090-5218 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-5218-1) | October 6, 2020 |
| 50090-5218-6 | 50090-5218 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-5218-6) | October 6, 2020 |
| 50090-5218-8 | 50090-5218 | A-S Medication Solutions | 45 TABLET in 1 BOTTLE (50090-5218-8) | October 27, 2022 |
| 50090-5218-9 | 50090-5218 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-5218-9) | October 6, 2020 |
| 50090-6603-0 | 50090-6603 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6603-0) | August 22, 2023 |
| 50090-6723-0 | 50090-6723 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6723-0) | October 5, 2023 |
| 50090-7439-2 | 50090-7439 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7439-2) | November 6, 2024 |
| 50090-7439-4 | 50090-7439 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7439-4) | November 6, 2024 |
| 50090-7943-0 | 50090-7943 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7943-0) | March 30, 2026 |
| 50090-7943-1 | 50090-7943 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7943-1) | March 30, 2026 |
| 50090-7943-6 | 50090-7943 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7943-6) | March 30, 2026 |
| 50090-7943-8 | 50090-7943 | A-S Medication Solutions | 45 TABLET in 1 BOTTLE (50090-7943-8) | March 30, 2026 |
| 50090-7943-9 | 50090-7943 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7943-9) | March 30, 2026 |
| 50090-7944-0 | 50090-7944 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7944-0) | March 30, 2026 |
| 50090-8077-0 | 50090-8077 | A-S Medication Solutions | 1000 TABLET in 1 BOTTLE (50090-8077-0) | September 16, 2026 |
| 50090-8080-0 | 50090-8080 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-8080-0) | September 17, 2026 |
| 50090-8080-2 | 50090-8080 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-8080-2) | September 17, 2026 |
| 50090-8080-3 | 50090-8080 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-8080-3) | September 17, 2026 |
| 16729-299-01 | 16729-299 | Accord Healthcare, Inc. | 100 TABLET in 1 BOTTLE (16729-299-01) | October 5, 2018 |
| 16729-299-17 | 16729-299 | Accord Healthcare, Inc. | 1000 TABLET in 1 BOTTLE (16729-299-17) | October 25, 2018 |
| 16729-300-01 | 16729-300 | Accord Healthcare, Inc. | 100 TABLET in 1 BOTTLE (16729-300-01) | October 5, 2018 |
| 16729-300-17 | 16729-300 | Accord Healthcare, Inc. | 1000 TABLET in 1 BOTTLE (16729-300-17) | October 9, 2018 |
| 16729-301-01 | 16729-301 | Accord Healthcare, Inc. | 100 TABLET in 1 BOTTLE (16729-301-01) | October 17, 2018 |
| 16729-301-16 | 16729-301 | Accord Healthcare, Inc. | 500 TABLET in 1 BOTTLE (16729-301-16) | October 23, 2018 |
| 16729-302-01 | 16729-302 | Accord Healthcare, Inc. | 100 TABLET in 1 BOTTLE (16729-302-01) | October 25, 2018 |
| 80425-0298-1 | 80425-0298 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET in 1 BOTTLE (80425-0298-1) | April 5, 2023 |
| 80425-0298-2 | 80425-0298 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET in 1 BOTTLE (80425-0298-2) | April 5, 2023 |
| 80425-0298-3 | 80425-0298 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET in 1 BOTTLE (80425-0298-3) | April 5, 2023 |
| 80425-0302-1 | 80425-0302 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET in 1 BOTTLE (80425-0302-1) | April 10, 2023 |
| 80425-0302-2 | 80425-0302 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET in 1 BOTTLE (80425-0302-2) | April 10, 2023 |
| 80425-0302-3 | 80425-0302 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET in 1 BOTTLE (80425-0302-3) | April 10, 2023 |
| 80425-0326-1 | 80425-0326 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET in 1 BOTTLE (80425-0326-1) | April 17, 2023 |
| 80425-0326-2 | 80425-0326 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET in 1 BOTTLE (80425-0326-2) | April 17, 2023 |
| 80425-0326-3 | 80425-0326 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET in 1 BOTTLE (80425-0326-3) | April 17, 2023 |
| 80425-0462-1 | 80425-0462 | Advanced Rx of Tennessee, LLC | 30 TABLET in 1 BOTTLE (80425-0462-1) | December 19, 2024 |
| 80425-0462-2 | 80425-0462 | Advanced Rx of Tennessee, LLC | 60 TABLET in 1 BOTTLE (80425-0462-2) | December 19, 2024 |
| 80425-0462-3 | 80425-0462 | Advanced Rx of Tennessee, LLC | 90 TABLET in 1 BOTTLE (80425-0462-3) | December 19, 2024 |
| 80425-0502-1 | 80425-0502 | Advanced Rx of Tennessee, LLC | 30 TABLET in 1 BOTTLE (80425-0502-1) | March 20, 2025 |
| 80425-0502-2 | 80425-0502 | Advanced Rx of Tennessee, LLC | 60 TABLET in 1 BOTTLE (80425-0502-2) | March 20, 2025 |
| 80425-0502-3 | 80425-0502 | Advanced Rx of Tennessee, LLC | 90 TABLET in 1 BOTTLE (80425-0502-3) | March 20, 2025 |
| 60687-432-01 | 60687-432 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-432-01) / 1 TABLET in 1 BLISTER PACK (60687-432-11) | May 3, 2019 |
| 60687-443-01 | 60687-443 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-443-01) / 1 TABLET in 1 BLISTER PACK (60687-443-11) | March 14, 2019 |
| 60687-454-01 | 60687-454 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-454-01) / 1 TABLET in 1 BLISTER PACK (60687-454-11) | March 15, 2019 |
| 60687-954-01 | 60687-954 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-954-01) / 1 TABLET in 1 BLISTER PACK (60687-954-11) | August 14, 2026 |
| 71610-511-30 | 71610-511 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-511-30) | December 29, 2020 |
| 71610-511-45 | 71610-511 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE (71610-511-45) | September 19, 2025 |
| 71610-511-53 | 71610-511 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-511-53) | October 28, 2025 |
| 71610-511-60 | 71610-511 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-511-60) | December 29, 2020 |
| 71610-511-80 | 71610-511 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-511-80) | December 29, 2020 |
| 71610-513-30 | 71610-513 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-513-30) | January 6, 2021 |
| 71610-513-60 | 71610-513 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-513-60) | January 4, 2021 |
| 71610-513-80 | 71610-513 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-513-80) | February 12, 2021 |
| 71610-514-30 | 71610-514 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-514-30) | January 6, 2021 |
| 71610-514-53 | 71610-514 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-514-53) | February 12, 2021 |
| 71610-525-15 | 71610-525 | Aphena Pharma Solutions - Tennessee, LLC | 15 TABLET in 1 BOTTLE (71610-525-15) | February 8, 2021 |
| 71610-525-30 | 71610-525 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-525-30) | February 8, 2021 |
| 71610-525-45 | 71610-525 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE (71610-525-45) | February 8, 2021 |
| 71610-525-53 | 71610-525 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-525-53) | February 8, 2021 |
| 71610-525-60 | 71610-525 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-525-60) | April 7, 2021 |
| 71610-525-70 | 71610-525 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET in 1 BOTTLE (71610-525-70) | February 8, 2021 |
| 71610-529-15 | 71610-529 | Aphena Pharma Solutions - Tennessee, LLC | 15 TABLET in 1 BOTTLE (71610-529-15) | July 16, 2024 |
| 71610-529-30 | 71610-529 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-529-30) | March 4, 2021 |
| 71610-529-45 | 71610-529 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE (71610-529-45) | August 11, 2021 |
| 71610-529-53 | 71610-529 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-529-53) | March 4, 2021 |
| 71610-529-60 | 71610-529 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-529-60) | March 4, 2021 |
| 71610-529-70 | 71610-529 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET in 1 BOTTLE (71610-529-70) | July 16, 2024 |
| 71610-530-30 | 71610-530 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-530-30) | March 9, 2021 |
| 71610-530-45 | 71610-530 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE (71610-530-45) | July 24, 2025 |
| 71610-530-53 | 71610-530 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-530-53) | March 9, 2021 |
| 71610-530-60 | 71610-530 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-530-60) | April 13, 2021 |
| 71610-530-80 | 71610-530 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-530-80) | March 9, 2021 |
| 71610-537-30 | 71610-537 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-537-30) | March 22, 2021 |
| 71610-537-45 | 71610-537 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE (71610-537-45) | September 15, 2025 |
| 71610-537-53 | 71610-537 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-537-53) | March 22, 2021 |
| 71610-537-60 | 71610-537 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-537-60) | March 22, 2021 |
| 71610-537-80 | 71610-537 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-537-80) | March 22, 2021 |
| 71610-874-30 | 71610-874 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-874-30) | January 29, 2025 |
| 71610-874-53 | 71610-874 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-874-53) | January 29, 2025 |
| 71610-874-60 | 71610-874 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-874-60) | January 29, 2025 |
| 71610-874-80 | 71610-874 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-874-80) | January 29, 2025 |
| 60505-2653-0 | 60505-2653 | Apotex Corp | 10 BLISTER PACK in 1 CARTON (60505-2653-0) / 10 TABLET in 1 BLISTER PACK | November 17, 2008 |
| 60505-2653-1 | 60505-2653 | Apotex Corp | 100 TABLET in 1 BOTTLE (60505-2653-1) | November 17, 2008 |
| 60505-2654-0 | 60505-2654 | Apotex Corp | 10 BLISTER PACK in 1 CARTON (60505-2654-0) / 10 TABLET in 1 BLISTER PACK | November 17, 2008 |
| 60505-2654-1 | 60505-2654 | Apotex Corp | 100 TABLET in 1 BOTTLE (60505-2654-1) | November 17, 2008 |
| 60505-2655-1 | 60505-2655 | Apotex Corp | 100 TABLET in 1 BOTTLE (60505-2655-1) | November 17, 2008 |
| 60505-2659-1 | 60505-2659 | Apotex Corp | 100 TABLET in 1 BOTTLE (60505-2659-1) | January 5, 2009 |
| 60505-2659-5 | 60505-2659 | Apotex Corp | 500 TABLET in 1 BOTTLE (60505-2659-5) | January 5, 2009 |
| 60505-2659-7 | 60505-2659 | Apotex Corp | 1400 TABLET in 1 BOTTLE (60505-2659-7) | January 5, 2009 |
| 76420-648-01 | 76420-648 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE (76420-648-01) | December 6, 2023 |
| 76420-648-30 | 76420-648 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-648-30) | December 6, 2023 |
| 76420-648-60 | 76420-648 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE (76420-648-60) | December 6, 2023 |
| 76420-648-90 | 76420-648 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE (76420-648-90) | December 6, 2023 |
| 76420-672-01 | 76420-672 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE (76420-672-01) | February 26, 2024 |
| 76420-672-30 | 76420-672 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-672-30) | February 26, 2024 |
| 76420-672-60 | 76420-672 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE (76420-672-60) | February 26, 2024 |
| 76420-672-90 | 76420-672 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE (76420-672-90) | February 26, 2024 |
| 76420-675-01 | 76420-675 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE (76420-675-01) | February 26, 2024 |
| 76420-675-30 | 76420-675 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-675-30) | February 26, 2024 |
| 76420-675-60 | 76420-675 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE (76420-675-60) | February 26, 2024 |
| 76420-675-90 | 76420-675 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE (76420-675-90) | February 26, 2024 |
| 76420-676-01 | 76420-676 | Asclemed USA, Inc. | 100 TABLET in 1 BOTTLE (76420-676-01) | February 26, 2024 |
| 76420-676-30 | 76420-676 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-676-30) | February 26, 2024 |
| 76420-676-60 | 76420-676 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE (76420-676-60) | February 26, 2024 |
| 76420-676-90 | 76420-676 | Asclemed USA, Inc. | 90 TABLET in 1 BOTTLE (76420-676-90) | February 26, 2024 |
| 59651-704-81 | 59651-704 | Aurobindo Pharma Limited | 8000 TABLET in 1 BAG (59651-704-81) | February 22, 2023 |
| 59651-705-59 | 59651-705 | Aurobindo Pharma Limited | 5000 TABLET in 1 BAG (59651-705-59) | February 22, 2023 |
| 59651-706-35 | 59651-706 | Aurobindo Pharma Limited | 3500 TABLET in 1 BAG (59651-706-35) | February 22, 2023 |
| 59651-707-38 | 59651-707 | Aurobindo Pharma Limited | 1800 TABLET in 1 BAG (59651-707-38) | February 22, 2023 |
| 13107-079-01 | 13107-079 | Aurolife Pharma LLC | 100 TABLET in 1 BOTTLE (13107-079-01) | September 15, 2015 |
| 13107-079-05 | 13107-079 | Aurolife Pharma LLC | 500 TABLET in 1 BOTTLE (13107-079-05) | September 15, 2015 |
| 13107-079-30 | 13107-079 | Aurolife Pharma LLC | 30 TABLET in 1 BOTTLE (13107-079-30) | September 15, 2015 |
| 13107-079-99 | 13107-079 | Aurolife Pharma LLC | 1000 TABLET in 1 BOTTLE (13107-079-99) | September 15, 2015 |
| 13107-080-01 | 13107-080 | Aurolife Pharma LLC | 100 TABLET in 1 BOTTLE (13107-080-01) | September 15, 2015 |
| 13107-080-05 | 13107-080 | Aurolife Pharma LLC | 500 TABLET in 1 BOTTLE (13107-080-05) | September 15, 2015 |
| 13107-080-30 | 13107-080 | Aurolife Pharma LLC | 30 TABLET in 1 BOTTLE (13107-080-30) | September 15, 2015 |
| 13107-080-99 | 13107-080 | Aurolife Pharma LLC | 1000 TABLET in 1 BOTTLE (13107-080-99) | September 15, 2015 |
| 13107-081-01 | 13107-081 | Aurolife Pharma LLC | 100 TABLET in 1 BOTTLE (13107-081-01) | September 15, 2015 |
| 13107-081-05 | 13107-081 | Aurolife Pharma LLC | 500 TABLET in 1 BOTTLE (13107-081-05) | September 15, 2015 |
| 13107-081-30 | 13107-081 | Aurolife Pharma LLC | 30 TABLET in 1 BOTTLE (13107-081-30) | September 15, 2015 |
| 13107-081-99 | 13107-081 | Aurolife Pharma LLC | 1000 TABLET in 1 BOTTLE (13107-081-99) | September 15, 2015 |
| 13107-082-01 | 13107-082 | Aurolife Pharma LLC | 100 TABLET in 1 BOTTLE (13107-082-01) | September 15, 2015 |
| 13107-082-05 | 13107-082 | Aurolife Pharma LLC | 500 TABLET in 1 BOTTLE (13107-082-05) | September 15, 2015 |
| 13107-082-30 | 13107-082 | Aurolife Pharma LLC | 30 TABLET in 1 BOTTLE (13107-082-30) | September 15, 2015 |
| 13107-082-99 | 13107-082 | Aurolife Pharma LLC | 1000 TABLET in 1 BOTTLE (13107-082-99) | September 15, 2015 |
| 42291-829-50 | 42291-829 | AvKARE | 500 TABLET in 1 BOTTLE (42291-829-50) | April 17, 2020 |
| 42291-829-90 | 42291-829 | AvKARE | 90 TABLET in 1 BOTTLE (42291-829-90) | April 17, 2020 |
| 42291-868-10 | 42291-868 | AvKARE | 1000 TABLET in 1 BOTTLE (42291-868-10) | November 6, 2020 |
| 42291-868-90 | 42291-868 | AvKARE | 90 TABLET in 1 BOTTLE (42291-868-90) | November 6, 2020 |
| 42291-869-10 | 42291-869 | AvKARE | 1000 TABLET in 1 BOTTLE (42291-869-10) | November 6, 2020 |
| 42291-869-90 | 42291-869 | AvKARE | 90 TABLET in 1 BOTTLE (42291-869-90) | November 6, 2020 |
| 50268-776-15 | 50268-776 | AvPAK | 50 BLISTER PACK in 1 BOX (50268-776-15) / 1 TABLET in 1 BLISTER PACK (50268-776-11) | February 21, 2020 |
| 71335-0705-0 | 71335-0705 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-0705-0) | August 12, 2019 |
| 71335-0705-1 | 71335-0705 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-0705-1) | February 14, 2020 |
| 71335-0705-2 | 71335-0705 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0705-2) | March 14, 2018 |
| 71335-0705-3 | 71335-0705 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0705-3) | March 7, 2018 |
| 71335-0705-4 | 71335-0705 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0705-4) | February 28, 2018 |
| 71335-0705-5 | 71335-0705 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-0705-5) | June 11, 2025 |
| 71335-0705-6 | 71335-0705 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-0705-6) | May 31, 2018 |
| 71335-0705-7 | 71335-0705 | Bryant Ranch Prepack | 25 TABLET in 1 BOTTLE (71335-0705-7) | June 11, 2025 |
| 71335-0705-8 | 71335-0705 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-0705-8) | February 26, 2020 |
| 71335-0705-9 | 71335-0705 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-0705-9) | June 11, 2025 |
| 71335-0730-1 | 71335-0730 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0730-1) | February 9, 2022 |
| 71335-0730-2 | 71335-0730 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0730-2) | February 9, 2022 |
| 71335-0730-3 | 71335-0730 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0730-3) | February 9, 2022 |
| 71335-0730-4 | 71335-0730 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-0730-4) | February 9, 2022 |
| 71335-0730-5 | 71335-0730 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-0730-5) | February 9, 2022 |
| 71335-0730-6 | 71335-0730 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-0730-6) | February 9, 2022 |
| 71335-0730-7 | 71335-0730 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-0730-7) | February 9, 2022 |
| 71335-0730-8 | 71335-0730 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-0730-8) | February 9, 2022 |
| 71335-0730-9 | 71335-0730 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-0730-9) | February 9, 2022 |
| 71335-0742-1 | 71335-0742 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0742-1) | February 9, 2022 |
| 71335-0742-2 | 71335-0742 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0742-2) | February 9, 2022 |
| 71335-0742-3 | 71335-0742 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0742-3) | February 9, 2022 |
| 71335-0742-4 | 71335-0742 | Bryant Ranch Prepack | 18 TABLET in 1 BOTTLE (71335-0742-4) | February 9, 2022 |
| 71335-0742-5 | 71335-0742 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-0742-5) | February 9, 2022 |
| 71335-0742-6 | 71335-0742 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-0742-6) | February 9, 2022 |
| 71335-0742-7 | 71335-0742 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-0742-7) | February 9, 2022 |
| 71335-1483-1 | 71335-1483 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1483-1) | January 15, 2020 |
| 71335-1483-2 | 71335-1483 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1483-2) | March 13, 2020 |
| 71335-1483-3 | 71335-1483 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1483-3) | August 12, 2021 |
| 71335-1483-4 | 71335-1483 | Bryant Ranch Prepack | 18 TABLET in 1 BOTTLE (71335-1483-4) | February 14, 2022 |
| 71335-1483-5 | 71335-1483 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1483-5) | February 14, 2022 |
| 71335-1483-6 | 71335-1483 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-1483-6) | February 14, 2022 |
| 71335-1483-7 | 71335-1483 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1483-7) | February 14, 2022 |
| 71335-1575-0 | 71335-1575 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-1575-0) | May 13, 2026 |
| 71335-1575-1 | 71335-1575 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-1575-1) | May 13, 2026 |
| 71335-1575-2 | 71335-1575 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1575-2) | April 13, 2020 |
| 71335-1575-3 | 71335-1575 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1575-3) | May 13, 2020 |
| 71335-1575-4 | 71335-1575 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1575-4) | May 27, 2020 |
| 71335-1575-5 | 71335-1575 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-1575-5) | May 13, 2026 |
| 71335-1575-6 | 71335-1575 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1575-6) | March 21, 2022 |
| 71335-1575-7 | 71335-1575 | Bryant Ranch Prepack | 25 TABLET in 1 BOTTLE (71335-1575-7) | May 13, 2026 |
| 71335-1575-8 | 71335-1575 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1575-8) | May 13, 2026 |
| 71335-1575-9 | 71335-1575 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1575-9) | May 13, 2026 |
| 71335-1630-1 | 71335-1630 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1630-1) | June 10, 2020 |
| 71335-1630-2 | 71335-1630 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1630-2) | February 14, 2022 |
| 71335-1630-3 | 71335-1630 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1630-3) | June 8, 2020 |
| 71335-1630-4 | 71335-1630 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1630-4) | February 14, 2022 |
| 71335-1630-5 | 71335-1630 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-1630-5) | July 23, 2020 |
| 71335-1630-6 | 71335-1630 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-1630-6) | February 14, 2022 |
| 71335-1630-7 | 71335-1630 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-1630-7) | February 14, 2022 |
| 71335-1630-8 | 71335-1630 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-1630-8) | February 14, 2022 |
| 71335-1630-9 | 71335-1630 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-1630-9) | February 14, 2022 |
| 71335-2084-1 | 71335-2084 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2084-1) | May 13, 2022 |
| 71335-2084-2 | 71335-2084 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2084-2) | May 27, 2022 |
| 71335-2084-3 | 71335-2084 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2084-3) | June 7, 2022 |
| 71335-2084-4 | 71335-2084 | Bryant Ranch Prepack | 18 TABLET in 1 BOTTLE (71335-2084-4) | October 31, 2024 |
| 71335-2084-5 | 71335-2084 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2084-5) | May 23, 2023 |
| 71335-2084-6 | 71335-2084 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-2084-6) | October 31, 2024 |
| 71335-2084-7 | 71335-2084 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-2084-7) | October 31, 2024 |
| 71335-2651-0 | 71335-2651 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-2651-0) | June 3, 2025 |
| 71335-2651-1 | 71335-2651 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-2651-1) | June 3, 2025 |
| 71335-2651-2 | 71335-2651 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2651-2) | June 3, 2025 |
| 71335-2651-3 | 71335-2651 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2651-3) | June 3, 2025 |
| 71335-2651-4 | 71335-2651 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2651-4) | June 3, 2025 |
| 71335-2651-5 | 71335-2651 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-2651-5) | June 3, 2025 |
| 71335-2651-6 | 71335-2651 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2651-6) | June 3, 2025 |
| 71335-2651-7 | 71335-2651 | Bryant Ranch Prepack | 25 TABLET in 1 BOTTLE (71335-2651-7) | June 3, 2025 |
| 71335-2651-8 | 71335-2651 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2651-8) | June 3, 2025 |
| 71335-2651-9 | 71335-2651 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-2651-9) | June 3, 2025 |
| 71335-3022-2 | 71335-3022 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-3022-2) | December 4, 2025 |
| 71335-3022-3 | 71335-3022 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-3022-3) | December 4, 2025 |
| 71335-3022-4 | 71335-3022 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE (71335-3022-4) | December 4, 2025 |
| 71335-3023-1 | 71335-3023 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (71335-3023-1) | December 4, 2025 |
| 71335-3024-1 | 71335-3024 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-3024-1) | December 4, 2025 |
| 71335-3024-2 | 71335-3024 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE (71335-3024-2) | December 4, 2025 |
| 71335-3025-1 | 71335-3025 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (71335-3025-1) | December 4, 2025 |
| 71335-3041-1 | 71335-3041 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-3041-1) | December 4, 2025 |
| 71335-3098-1 | 71335-3098 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-3098-1) | March 13, 2026 |
| 71335-3098-2 | 71335-3098 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-3098-2) | March 13, 2026 |
| 71335-3098-3 | 71335-3098 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-3098-3) | March 13, 2026 |
| 71335-3098-4 | 71335-3098 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-3098-4) | March 13, 2026 |
| 71335-3098-5 | 71335-3098 | Bryant Ranch Prepack | 28 TABLET in 1 BOTTLE (71335-3098-5) | March 13, 2026 |
| 71335-3098-6 | 71335-3098 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-3098-6) | March 13, 2026 |
| 71335-3098-7 | 71335-3098 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-3098-7) | March 13, 2026 |
| 71335-3098-8 | 71335-3098 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-3098-8) | March 13, 2026 |
| 71335-3098-9 | 71335-3098 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-3098-9) | March 13, 2026 |
| 71335-3112-1 | 71335-3112 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-3112-1) | March 30, 2026 |
| 71335-3112-2 | 71335-3112 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-3112-2) | March 30, 2026 |
| 71335-3112-3 | 71335-3112 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-3112-3) | March 30, 2026 |
| 71335-3112-4 | 71335-3112 | Bryant Ranch Prepack | 18 TABLET in 1 BOTTLE (71335-3112-4) | March 30, 2026 |
| 71335-3112-5 | 71335-3112 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-3112-5) | March 30, 2026 |
| 71335-3112-6 | 71335-3112 | Bryant Ranch Prepack | 45 TABLET in 1 BOTTLE (71335-3112-6) | March 30, 2026 |
| 71335-3112-7 | 71335-3112 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-3112-7) | March 30, 2026 |
| 72162-2531-0 | 72162-2531 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE (72162-2531-0) | September 19, 2025 |
| 72162-2531-1 | 72162-2531 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-2531-1) | September 19, 2025 |
| 72162-2531-3 | 72162-2531 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (72162-2531-3) | September 19, 2025 |
| 72162-2531-5 | 72162-2531 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-2531-5) | September 19, 2025 |
| 72162-2531-9 | 72162-2531 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (72162-2531-9) | September 19, 2025 |
| 72162-2532-0 | 72162-2532 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE (72162-2532-0) | September 19, 2025 |
| 72162-2532-1 | 72162-2532 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-2532-1) | September 19, 2025 |
| 72162-2532-5 | 72162-2532 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-2532-5) | September 19, 2025 |
| 72162-2532-9 | 72162-2532 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (72162-2532-9) | September 19, 2025 |
| 72162-2533-1 | 72162-2533 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-2533-1) | September 19, 2025 |
| 72162-2533-5 | 72162-2533 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-2533-5) | September 19, 2025 |
| 55154-8085-0 | 55154-8085 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-8085-0) / 1 TABLET in 1 BLISTER PACK | December 11, 2017 |
| 55154-8087-0 | 55154-8087 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-8087-0) / 1 TABLET in 1 BLISTER PACK | December 11, 2017 |
| 67046-1506-3 | 67046-1506 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-1506-3) | January 24, 2025 |
| 67046-1540-3 | 67046-1540 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-1540-3) | March 25, 2025 |
| 51407-946-01 | 51407-946 | Golden State Medical Supply, Inc. | 100 TABLET in 1 BOTTLE (51407-946-01) | April 28, 2026 |
| 51407-946-05 | 51407-946 | Golden State Medical Supply, Inc. | 500 TABLET in 1 BOTTLE (51407-946-05) | April 28, 2026 |
| 51407-946-10 | 51407-946 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE (51407-946-10) | April 28, 2026 |
| 51407-946-90 | 51407-946 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE (51407-946-90) | April 28, 2026 |
| 51407-947-01 | 51407-947 | Golden State Medical Supply, Inc. | 100 TABLET in 1 BOTTLE (51407-947-01) | April 28, 2026 |
| 51407-947-05 | 51407-947 | Golden State Medical Supply, Inc. | 500 TABLET in 1 BOTTLE (51407-947-05) | April 28, 2026 |
| 51407-947-10 | 51407-947 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE (51407-947-10) | April 28, 2026 |
| 51407-947-90 | 51407-947 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE (51407-947-90) | April 28, 2026 |
| 70010-231-01 | 70010-231 | Granules Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (70010-231-01) | August 9, 2024 |
| 70010-231-03 | 70010-231 | Granules Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (70010-231-03) | August 9, 2024 |
| 70010-231-05 | 70010-231 | Granules Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (70010-231-05) | August 9, 2024 |
| 70010-231-10 | 70010-231 | Granules Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (70010-231-10) | October 1, 2024 |
| 70010-232-01 | 70010-232 | Granules Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (70010-232-01) | August 9, 2024 |
| 70010-232-03 | 70010-232 | Granules Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (70010-232-03) | August 9, 2024 |
| 70010-232-05 | 70010-232 | Granules Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (70010-232-05) | August 9, 2024 |
| 70010-232-10 | 70010-232 | Granules Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (70010-232-10) | October 1, 2024 |
| 70010-233-01 | 70010-233 | Granules Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (70010-233-01) | August 9, 2024 |
| 70010-233-03 | 70010-233 | Granules Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (70010-233-03) | August 9, 2024 |
| 70010-233-05 | 70010-233 | Granules Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (70010-233-05) | August 9, 2024 |
| 70010-234-01 | 70010-234 | Granules Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (70010-234-01) | August 9, 2024 |
| 70010-234-03 | 70010-234 | Granules Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (70010-234-03) | August 9, 2024 |
| 70010-234-05 | 70010-234 | Granules Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (70010-234-05) | August 9, 2024 |
| 0904-6868-61 | 0904-6868 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-6868-61) / 1 TABLET in 1 BLISTER PACK | December 11, 2017 |
| 0904-6869-61 | 0904-6869 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-6869-61) / 1 TABLET in 1 BLISTER PACK | December 11, 2017 |
| 0904-7212-61 | 0904-7212 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7212-61) / 1 TABLET in 1 BLISTER PACK | December 11, 2017 |
| 45865-167-30 | 45865-167 | Medsource Pharmaceuticals | 30 TABLET in 1 BOTTLE (45865-167-30) | September 8, 2021 |
| 45865-167-60 | 45865-167 | Medsource Pharmaceuticals | 60 TABLET in 1 BOTTLE (45865-167-60) | April 8, 2021 |
| 45865-505-60 | 45865-505 | Medsource Pharmaceuticals | 60 TABLET in 1 BOTTLE (45865-505-60) | November 16, 2023 |
| 0615-8339-05 | 0615-8339 | NCS HealthCare of KY, LLC dba Vangard Labs | 15 TABLET in 1 BLISTER PACK (0615-8339-05) | August 23, 2023 |
| 0615-8339-39 | 0615-8339 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET in 1 BLISTER PACK (0615-8339-39) | January 27, 2022 |
| 0615-8371-05 | 0615-8371 | NCS HealthCare of KY, LLC dba Vangard Labs | 15 TABLET in 1 BLISTER PACK (0615-8371-05) | February 11, 2022 |
| 0615-8371-07 | 0615-8371 | NCS HealthCare of KY, LLC dba Vangard Labs | 7 TABLET in 1 BLISTER PACK (0615-8371-07) | December 8, 2022 |
| 0615-8371-14 | 0615-8371 | NCS HealthCare of KY, LLC dba Vangard Labs | 14 TABLET in 1 BLISTER PACK (0615-8371-14) | December 8, 2022 |
| 0615-8371-28 | 0615-8371 | NCS HealthCare of KY, LLC dba Vangard Labs | 28 TABLET in 1 BLISTER PACK (0615-8371-28) | March 29, 2024 |
| 0615-8371-39 | 0615-8371 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET in 1 BLISTER PACK (0615-8371-39) | February 11, 2022 |
| 0615-8386-05 | 0615-8386 | NCS HealthCare of KY, LLC dba Vangard Labs | 15 TABLET in 1 BLISTER PACK (0615-8386-05) | February 10, 2021 |
| 0615-8386-28 | 0615-8386 | NCS HealthCare of KY, LLC dba Vangard Labs | 28 TABLET in 1 BLISTER PACK (0615-8386-28) | January 22, 2025 |
| 0615-8386-39 | 0615-8386 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET in 1 BLISTER PACK (0615-8386-39) | February 10, 2021 |
| 51655-366-26 | 51655-366 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-366-26) | January 5, 2023 |
| 51655-366-52 | 51655-366 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-366-52) | November 30, 2022 |
| 51655-986-26 | 51655-986 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-986-26) | May 18, 2022 |
| 51655-986-52 | 51655-986 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-986-52) | May 18, 2022 |
| 68071-2959-3 | 68071-2959 | NuCare Pharmaceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-2959-3) | March 27, 2023 |
| 68071-2959-6 | 68071-2959 | NuCare Pharmaceuticals,Inc. | 60 TABLET in 1 BOTTLE (68071-2959-6) | March 27, 2023 |
| 68071-2996-9 | 68071-2996 | NuCare Pharmaceuticals,Inc. | 90 TABLET in 1 BOTTLE (68071-2996-9) | May 26, 2023 |
| 68071-4410-2 | 68071-4410 | NuCare Pharmaceuticals,Inc. | 20 TABLET in 1 BOTTLE (68071-4410-2) | April 27, 2018 |
| 68071-4410-3 | 68071-4410 | NuCare Pharmaceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-4410-3) | April 27, 2018 |
| 68071-4410-4 | 68071-4410 | NuCare Pharmaceuticals,Inc. | 45 TABLET in 1 BOTTLE (68071-4410-4) | April 27, 2018 |
| 68071-4410-5 | 68071-4410 | NuCare Pharmaceuticals,Inc. | 56 TABLET in 1 BOTTLE (68071-4410-5) | April 27, 2018 |
| 68071-4410-6 | 68071-4410 | NuCare Pharmaceuticals,Inc. | 60 TABLET in 1 BOTTLE (68071-4410-6) | April 27, 2018 |
| 68071-4410-8 | 68071-4410 | NuCare Pharmaceuticals,Inc. | 28 TABLET in 1 BOTTLE (68071-4410-8) | April 27, 2018 |
| 68071-4410-9 | 68071-4410 | NuCare Pharmaceuticals,Inc. | 90 TABLET in 1 BOTTLE (68071-4410-9) | April 27, 2018 |
| 68071-4833-1 | 68071-4833 | NuCare Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (68071-4833-1) | April 4, 2019 |
| 68071-4761-3 | 68071-4761 | NuCare Pharmceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-4761-3) | February 11, 2019 |
| 68071-4761-5 | 68071-4761 | NuCare Pharmceuticals,Inc. | 45 TABLET in 1 BOTTLE (68071-4761-5) | February 11, 2019 |
| 68071-4761-6 | 68071-4761 | NuCare Pharmceuticals,Inc. | 60 TABLET in 1 BOTTLE (68071-4761-6) | February 11, 2019 |
| 68071-4761-9 | 68071-4761 | NuCare Pharmceuticals,Inc. | 90 TABLET in 1 BOTTLE (68071-4761-9) | February 11, 2019 |
| 72789-079-30 | 72789-079 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-079-30) | April 6, 2020 |
| 72789-154-30 | 72789-154 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-154-30) | February 1, 2021 |
| 72789-154-60 | 72789-154 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE, PLASTIC (72789-154-60) | February 1, 2021 |
| 72789-154-90 | 72789-154 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (72789-154-90) | January 12, 2021 |
| 72789-168-30 | 72789-168 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-168-30) | March 25, 2021 |
| 72789-168-90 | 72789-168 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (72789-168-90) | February 22, 2021 |
| 72789-424-30 | 72789-424 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-424-30) | August 6, 2024 |
| 72789-424-90 | 72789-424 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (72789-424-90) | August 12, 2024 |
| 72789-588-90 | 72789-588 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (72789-588-90) | August 19, 2026 |
| 72789-591-30 | 72789-591 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-591-30) | September 17, 2026 |
| 72789-591-90 | 72789-591 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (72789-591-90) | September 2, 2026 |
| 68788-7118-1 | 68788-7118 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-7118-1) | March 9, 2018 |
| 68788-7118-3 | 68788-7118 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-7118-3) | March 9, 2018 |
| 68788-7118-6 | 68788-7118 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-7118-6) | March 9, 2018 |
| 68788-7118-9 | 68788-7118 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-7118-9) | March 9, 2018 |
| 68788-7137-1 | 68788-7137 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-7137-1) | April 10, 2018 |
| 68788-7137-3 | 68788-7137 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-7137-3) | April 10, 2018 |
| 68788-7137-6 | 68788-7137 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-7137-6) | April 10, 2018 |
| 68788-7137-8 | 68788-7137 | Preferred Pharmaceuticals Inc. | 28 TABLET in 1 BOTTLE (68788-7137-8) | April 10, 2018 |
| 68788-7137-9 | 68788-7137 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-7137-9) | April 10, 2018 |
| 68788-7166-1 | 68788-7166 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-7166-1) | June 5, 2018 |
| 68788-7166-3 | 68788-7166 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-7166-3) | June 5, 2018 |
| 68788-7166-6 | 68788-7166 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-7166-6) | June 5, 2018 |
| 68788-7166-9 | 68788-7166 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-7166-9) | June 5, 2018 |
| 71205-505-30 | 71205-505 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-505-30) | November 16, 2020 |
| 71205-505-60 | 71205-505 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-505-60) | November 16, 2020 |
| 71205-505-90 | 71205-505 | Proficient Rx LP | 90 TABLET in 1 CARTON (71205-505-90) | November 16, 2020 |
| 71205-551-30 | 71205-551 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-551-30) | April 2, 2021 |
| 71205-551-60 | 71205-551 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-551-60) | April 2, 2021 |
| 71205-551-90 | 71205-551 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-551-90) | April 2, 2021 |
| 71205-568-30 | 71205-568 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-568-30) | May 17, 2021 |
| 71205-568-60 | 71205-568 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-568-60) | May 17, 2021 |
| 71205-568-90 | 71205-568 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-568-90) | May 17, 2021 |
| 71205-574-30 | 71205-574 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-574-30) | June 8, 2021 |
| 71205-574-60 | 71205-574 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-574-60) | June 8, 2021 |
| 71205-574-90 | 71205-574 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-574-90) | June 8, 2021 |
| 71205-630-30 | 71205-630 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-630-30) | January 7, 2022 |
| 71205-630-60 | 71205-630 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-630-60) | January 7, 2022 |
| 71205-630-90 | 71205-630 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-630-90) | January 7, 2022 |
| 71205-815-30 | 71205-815 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-815-30) | June 19, 2023 |
| 71205-815-60 | 71205-815 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-815-60) | June 19, 2023 |
| 71205-815-90 | 71205-815 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-815-90) | June 19, 2023 |
| 70518-1204-3 | 70518-1204 | REMEDYREPACK INC. | 30 TABLET in 1 BOTTLE, PLASTIC (70518-1204-3) | December 15, 2023 |
| 70518-1204-4 | 70518-1204 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-1204-4) | June 20, 2025 |
| 70518-2180-2 | 70518-2180 | REMEDYREPACK INC. | 30 TABLET in 1 BOTTLE, PLASTIC (70518-2180-2) | October 17, 2025 |
| 70518-2929-0 | 70518-2929 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-2929-0) | October 31, 2020 |
| 70518-2929-8 | 70518-2929 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-2929-8) | March 20, 2026 |
| 70518-2973-0 | 70518-2973 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-2973-0) | January 12, 2021 |
| 70518-2973-2 | 70518-2973 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-2973-2) | June 9, 2021 |
| 70518-3290-4 | 70518-3290 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3290-4) | May 15, 2024 |
| 70518-3290-5 | 70518-3290 | REMEDYREPACK INC. | 30 TABLET in 1 BOTTLE, PLASTIC (70518-3290-5) | March 24, 2025 |
| 70518-3403-2 | 70518-3403 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-3403-2) | September 20, 2023 |
| 70518-3426-1 | 70518-3426 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3426-1) | May 29, 2024 |
| 70518-3479-1 | 70518-3479 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-3479-1) | May 24, 2023 |
| 70518-3756-0 | 70518-3756 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-3756-0) | June 11, 2023 |
| 70518-4441-0 | 70518-4441 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-4441-0) | August 14, 2025 |
| 70518-4690-0 | 70518-4690 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-4690-0) | July 3, 2026 |
| 70518-4737-0 | 70518-4737 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4737-0) | August 26, 2026 |
| 70518-4737-1 | 70518-4737 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-4737-1) | August 27, 2026 |
| 70518-4760-0 | 70518-4760 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-4760-0) / 1 TABLET in 1 POUCH (70518-4760-1) | September 22, 2026 |
| 64980-672-01 | 64980-672 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (64980-672-01) | January 29, 2025 |
| 64980-672-10 | 64980-672 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (64980-672-10) | April 11, 2025 |
| 64980-672-50 | 64980-672 | Rising Pharma Holdings, Inc. | 500 TABLET in 1 BOTTLE (64980-672-50) | January 29, 2025 |
| 64980-673-01 | 64980-673 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (64980-673-01) | January 29, 2025 |
| 64980-673-10 | 64980-673 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (64980-673-10) | April 11, 2025 |
| 64980-673-50 | 64980-673 | Rising Pharma Holdings, Inc. | 500 TABLET in 1 BOTTLE (64980-673-50) | January 29, 2025 |
| 64980-674-01 | 64980-674 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (64980-674-01) | January 29, 2025 |
| 64980-674-50 | 64980-674 | Rising Pharma Holdings, Inc. | 500 TABLET in 1 BOTTLE (64980-674-50) | January 29, 2025 |
| 64980-675-01 | 64980-675 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (64980-675-01) | January 29, 2025 |
| 60760-806-60 | 60760-806 | St. Mary's Medical Park Pharmacy | 60 TABLET in 1 BOTTLE, PLASTIC (60760-806-60) | April 25, 2018 |
| 60760-806-90 | 60760-806 | St. Mary's Medical Park Pharmacy | 90 TABLET in 1 BOTTLE, PLASTIC (60760-806-90) | May 13, 2025 |
| 57664-053-72 | 57664-053 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (57664-053-72) | October 3, 2022 |
| 57664-053-74 | 57664-053 | Sun Pharmaceutical Industries, Inc. | 500 TABLET in 1 BOTTLE, PLASTIC (57664-053-74) | October 3, 2022 |
| 0555-0711-02 | 0555-0711 | Teva Pharmaceuticals USA, Inc. | 100 TABLET in 1 BOTTLE (0555-0711-02) | December 9, 2021 |
| 50111-450-01 | 50111-450 | Teva Pharmaceuticals USA, Inc. | 100 TABLET in 1 BOTTLE (50111-450-01) | March 11, 2020 |
| 50111-450-02 | 50111-450 | Teva Pharmaceuticals USA, Inc. | 500 TABLET in 1 BOTTLE (50111-450-02) | March 11, 2020 |
| 50111-450-88 | 50111-450 | Teva Pharmaceuticals USA, Inc. | 23500 TABLET in 1 CONTAINER (50111-450-88) | June 20, 2025 |
| 50111-560-01 | 50111-560 | Teva Pharmaceuticals USA, Inc. | 100 TABLET in 1 BOTTLE (50111-560-01) | October 1, 2020 |
| 50111-560-02 | 50111-560 | Teva Pharmaceuticals USA, Inc. | 500 TABLET in 1 BOTTLE (50111-560-02) | January 13, 2021 |
| 50111-560-03 | 50111-560 | Teva Pharmaceuticals USA, Inc. | 1000 TABLET in 1 BOTTLE (50111-560-03) | October 1, 2020 |
| 50111-560-88 | 50111-560 | Teva Pharmaceuticals USA, Inc. | 70000 TABLET in 1 CONTAINER (50111-560-88) | June 20, 2025 |
| 50111-561-01 | 50111-561 | Teva Pharmaceuticals USA, Inc. | 100 TABLET in 1 BOTTLE (50111-561-01) | December 8, 2020 |
| 50111-561-02 | 50111-561 | Teva Pharmaceuticals USA, Inc. | 500 TABLET in 1 BOTTLE (50111-561-02) | December 8, 2020 |
| 50111-561-03 | 50111-561 | Teva Pharmaceuticals USA, Inc. | 1000 TABLET in 1 BOTTLE (50111-561-03) | October 8, 2020 |
| 50111-561-88 | 50111-561 | Teva Pharmaceuticals USA, Inc. | 35000 TABLET in 1 CONTAINER (50111-561-88) | June 20, 2025 |
| 13668-330-01 | 13668-330 | Torrent Pharmaceuticals Limited | 100 TABLET in 1 BOTTLE (13668-330-01) | November 27, 2013 |
| 13668-330-05 | 13668-330 | Torrent Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (13668-330-05) | November 27, 2013 |
| 13668-330-10 | 13668-330 | Torrent Pharmaceuticals Limited | 1000 TABLET in 1 BOTTLE (13668-330-10) | November 27, 2013 |
| 13668-330-30 | 13668-330 | Torrent Pharmaceuticals Limited | 30 TABLET in 1 BOTTLE (13668-330-30) | November 27, 2013 |
| 13668-331-01 | 13668-331 | Torrent Pharmaceuticals Limited | 100 TABLET in 1 BOTTLE (13668-331-01) | November 27, 2013 |
| 13668-331-05 | 13668-331 | Torrent Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (13668-331-05) | November 27, 2013 |
| 13668-331-10 | 13668-331 | Torrent Pharmaceuticals Limited | 1000 TABLET in 1 BOTTLE (13668-331-10) | November 27, 2013 |
| 13668-331-30 | 13668-331 | Torrent Pharmaceuticals Limited | 30 TABLET in 1 BOTTLE (13668-331-30) | November 27, 2013 |
| 13668-332-01 | 13668-332 | Torrent Pharmaceuticals Limited | 100 TABLET in 1 BOTTLE (13668-332-01) | November 27, 2013 |
| 13668-332-05 | 13668-332 | Torrent Pharmaceuticals Limited | 500 TABLET in 1 BOTTLE (13668-332-05) | November 27, 2013 |
| 13668-332-10 | 13668-332 | Torrent Pharmaceuticals Limited | 1000 TABLET in 1 BOTTLE (13668-332-10) | November 27, 2013 |
| 13668-332-30 | 13668-332 | Torrent Pharmaceuticals Limited | 30 TABLET in 1 BOTTLE (13668-332-30) | November 27, 2013 |
| 13668-333-01 | 13668-333 | Torrent Pharmaceuticals Limited | 100 TABLET in 1 BOTTLE (13668-333-01) | November 27, 2013 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 13 sections on this page.