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Amoxicillin and Clavulanate Potassium
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 |
|---|---|---|
| Penicillin-class Antibacterial [EPC] | EPC | All 38 members |
| Penicillins [CS] | CS | All 38 members |
| beta Lactamase Inhibitor [EPC] | EPC | All 15 members |
| beta Lactamase Inhibitors [MoA] | MoA | All 15 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 091568-001 | AMOXICILLIN AND CLAVULANATE POTASSIUM | TABLET | AMOXICILLIN; CLAVULANATE POTASSIUM | 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 | 25 | Labeling | Approved | November 26, 2024 | Standard |
| Supplement | 24 | Labeling | Approved | May 6, 2024 | Standard |
| Supplement | 18 | Labeling | Approved | May 6, 2024 | Standard |
| Supplement | 14 | Labeling | Approved | May 6, 2024 | Standard |
| Supplement | 11 | Labeling | Approved | May 6, 2024 | Standard |
| Supplement | 2 | Labeling | Approved | July 23, 2015 | Standard |
| Original application | 1 | Approved | January 20, 2012 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260812). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug Labeling[Insert boxed warning highlight title] See full prescribing information for complete boxed warning [Insert boxed warning highlight text]
Recent Major Changes
openFDA Drug LabelingWarnings and Precautions ( 5 ) 8/2022 Warnings and Precautions, Drug-Induced Enterocolitis Syndrome (DIES) ( 5.3 ) 05/2024
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: • Lower Respiratory Tract Infections – caused by beta–lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . • Acute Bacterial Otitis Media – caused by beta–lactamase–producing isolates of H. influenzae and M. catarrhalis . • Sinusitis – caused by beta–lactamase–producing isolates of H. influenzae and M. catarrhalis . • Skin and Skin Structure Infections – caused by beta–lactamase–producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species. • Urinary Tract Infections – caused by beta–lactamase–producing isolates of E. coli , Klebsiella species, and Enterobacter species. Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta–lactamase production, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should not be used. Usage To reduce the development of drug–resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are combination of amoxicillin, a penicillin–class antibacterial and clavulanate potassium, a beta–lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: ( 1 ) • Lower respiratory tract infections • Acute bacterial otitis media • Sinusitis • Skin and skin structure infections • Urinary tract infections Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta–lactamase production, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should not be used. ( 1 ) Usage To reduce the development of drug–resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )
Dosage and Administration
openFDA Drug Labeling2 DOSAGE AND ADMINISTRATION • Adults and Pediatric Patients greater than 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours, based on amoxicillin component. ( 2.2 , 2.3 ) • Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. ( 2.3 ) • Neonates and infants less than 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/5 mL oral suspension is recommended. ( 2.3 ) 2.1 Important Administration Instructions Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal. 2.2 Adult Patients See dosing regimens of amoxicillin and clavulanate potassium (based on the amoxicillin component) provided in Table 1 below. Table 1: Dosing Regimens of Amoxicillin and Clavulanate Potassium in Adult Patients TYPE OF INFECTION DOSING REGIMEN OF AMOXICILLIN AND CLAVULANATE POTASSIUM Severe infections and infections of the respiratory tract one 875 mg tablet* of amoxicillin and clavulanate potassium every 12 hours or one 500 mg tablet †, ‡ of amoxicillin and clavulanate potassium every 8 hours Less severe infections one 500 mg tablet †, ‡ of amoxicillin and clavulanate potassium every 12 hours or one 250 mg tablet § of amoxicillin and clavulanate potassium every 8 hours * Adults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL suspension or the amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL suspension may be used in place of the 875 mg/125 mg tablet. † Adults who have difficulty swallowing may be given the amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL or amoxicillin and clavulanate potassium 250 mg/62.5 mg per 5 mL suspension in place of the 500 mg/125 mg tablet. ‡ Two amoxicillin and clavulanate potassium 250 mg/125 mg tablets are NOT substitutable with one 500 mg/125 mg amoxicillin and clavulanate potassium tablet [see Dosage and Administration ( 2.6 )] . § amoxicillin and clavulanate potassium 250 mg/125 mg tablet is NOT substitutable with amoxicillin and clavulanate potassium 250 mg/62.5 mg chewable tablet [see Dosage and Administration ( 2.6 )] . 2.3 Pediatric Patients Based on the amoxicillin component, amoxicillin and clavulanate potassium should be dosed as follows: Neonates and Infants Aged less than 12 weeks (less than 3 months): See dosing regimens of amoxicillin and clavulanate potassium provided in Table 2 below. Table 2: Dosing Regimens of Amoxicillin and Clavulanate Potassium in Neonates and Infants Aged Less than 12 Weeks (Less than 3 Months) PATIENT POPULATION DOSING REGIMEN Amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension* Neonates and Infants aged less than 12 weeks (less than 3 months) 30 mg/kg/day every 12 hours * Experience with the amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL formulation in this age group is limited, and thus, use of the amoxicillin and clavulanate potassium 125 mg/31.25 mg per 5 mL for oral suspension is recommended. Patients Aged 12 weeks (3 months) and Older and Weighing Less than 40 kg: See dosing regimens provided in Table 3 below. • The every 12 hour regimen is recommended as it is associated with significantly less diarrhea [see Clinical Studies ( 14.2 )] . • The amoxicillin and clavulanate potassium 200 mg/28.5 mg per 5 mL and amoxicillin and clavulanate potassium 400 mg/57 mg per 5 mL for oral suspension and amoxicillin and clavulanate potassium 200 mg/28.5 mg and amoxicillin and clavulanate potassium 400 mg/57 mg chewable tablets contain aspartame and should not be used by phenylketonurics [see Warnings and Preca …
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 250 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule shaped, debossed GGN5 on one side and plain on the reverse side, and contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg: Each film coated tablet, for oral administration, is white, oval-shaped, debossed GGN6 on one side and plain on the reverse side, and contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule-shaped, scored and debossed GGN7 on one side and scored on the reverse side, and contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. For Oral Suspension Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 200 mg/28.5 mg per 5 mL: as a dry, white powder. Each 5 mL of reconstituted orange-flavored suspension contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt. Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 400 mg/57 mg per 5 mL: as a dry, white powder. Each 5 mL of reconstituted orange-flavored suspension contains 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. Chewable Tablets Amoxicillin and Clavulanate Potassium Tablets, USP, (Chewable) 200 mg/28.5 mg: Each chewable tablet is round, pink, cherry-banana flavored, embossed GGN2 on one side and plain on the reverse side, and contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt. Amoxicillin and Clavulanate Potassium Tablets, USP, (Chewable) 400 mg/57 mg: Each chewable tablet is round, pink, cherry-banana flavored, embossed GGN4 on one side and plain on the reverse side, and contains 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet should NOT be substituted for each other, as they are not interchangeable and the 250-mg tablet should not be used in children weighing less than 40 kg. The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid. The 250-mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid. Two 250 mg tablets of amoxicillin and clavulanate potassium should NOT be substituted for one 500 mg tablet of amoxicillin and clavulanate potassium. Since both the 250 mg and 500 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets of amoxicillin and clavulanate potassium are not equivalent to one 500 mg tablet of amoxicillin and clavulanate potassium. Formulations and amoxicillin/clavulanate content are: • Tablets: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg tablets are scored ( 3 ) • For Oral Suspension: 200 mg/28.5 mg per 5 mL, 400 mg/57 mg per 5 mL ( 3 ) • Chewable Tablets: 200 mg/28.5 mg, 400 mg/57 mg ( 3 )
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium tablets or to other beta-lactams (e.g., penicillins or cephalosporins). ( 4.1 ) • History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets. ( 4.2 ) 4.1 Serious Hypersensitivity Reactions Amoxicillin and clavulanate potassium tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). 4.2 Cholestatic Jaundice/Hepatic Dysfunction Amoxicillin and clavulanate potassium tablets are contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets.
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS • Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) if a reaction occurs. ( 5.1 ) • Severe Cutaneous Adverse Reactions (SCAR): Monitor closely. Discontinue if rash progresses. ( 5.2 ) • Drug-induced enterocolitis syndrome (DIES) has been reported with the use of amoxicillin, a component of amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable). If this occurs, discontinue amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) and institute appropriate therapy. ( 5.3 ) • Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. ( 5.4 ) • Clostridioides difficile –associated diarrhea (CDAD): Evaluate patients if diarrhea occurs. ( 5.5 ) • Patients with mononucleosis who receive amoxicillin/clavulanate potassium develop skin rash. Avoid amoxicillin/clavulanate potassium use in these patients. ( 5.6 ) • Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. ( 5.7 ) 5.1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterials, including amoxicillin/clavulanate potassium. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable), careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be discontinued, and appropriate therapy instituted. 5.2 Severe Cutaneous Adverse Reactions Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) may cause severe cutaneous adverse reactions (SCAR), such as Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If patients develop a skin rash, they should be monitored closely, and amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) discontinued if lesions progress. 5.3 Drug-Induced Enterocolitis Syndrome (DIES) Drug-induced enterocolitis syndrome (DIES) has been reported with the use of amoxicillin, a component of amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable), [see Adverse Reactions ( )] , with most cases occurring in pediatric patients ≤18 years of age. DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms. DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours after ingesting amoxicillin, and leukocytosis with neutrophilia. If DIES occurs, discontinue amoxicillin and clavulanate potassium tablets, amoxicilli …
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions ( 5.3 )] Hepatic Dysfunction [see Warnings and Precautions ( 5.4 )] Clostridioides difficile Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.5 )] The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Devatis, Inc. at 1-833-534-4406 or druginfo@devatis.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial 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. The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug-related adverse reactions. The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions ( less than 1%) include: Abdominal discomfort, flatulence, and headache. In pediatric patients (aged 2 months to 12 years), 1 US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of amoxicillin and clavulanate potassium for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of amoxicillin and clavulanate potassium for 10 days in the treatment of acute otitis media. A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes [see Clinical Studies ( 14.2 )] . 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of amoxicillin and clavulanate potassium. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to amoxicillin and clavulanate potassium. Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [ see Warnings and Precautions ( 5.5 ) ]. Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [ see Warnings and Precautions ( 5.1 ) ]. Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis. Liver: Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with amoxicillin and clavulanate potassium. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic hepatocellular changes. The onse …
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS • Co-administration with probenecid is not recommended. ( 7.1 ) • Concomitant use of amoxicillin and clavulanate potassium tablets and oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) • Co-administration with allopurinol increases the risk of rash. ( 7.3 ) • Amoxicillin and clavulanate potassium tablets may reduce efficacy of oral contraceptives. ( 7.4 ) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin but does not delay renal excretion of clavulanic acid. Concurrent use with amoxicillin and clavulanate potassium tablets may result in increased and prolonged blood concentrations of amoxicillin. Co-administration of probenecid is not recommended. 7.2 Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently with amoxicillin and clavulanate potassium tablets. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. 7.3 Allopurinol The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of amoxicillin rashes is due to allopurinol or the hyperuricemia present in these patients. 7.4 Oral Contraceptives Amoxicillin and clavulanate potassium may affect intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. 7.5 Effects on Laboratory Tests High urine concentrations of amoxicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ® , Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin and clavulanate potassium tablets, it is recommended that glucose tests based on enzymatic glucose oxidase reactions be used. Following administration of amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS Pediatric Use: Modify dose in patients 12 weeks or younger. ( 8.4 ) Renal Impairment: Dosage adjustment is recommended for severe renal impairment (GFR less than 30 mL/min). ( 2.4 , 8.6 ) 8.1 Pregnancy Teratogenic Effects : Reproduction studies performed in pregnant rats and mice given amoxicillin/clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin/clavulanate potassium. The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). There are, however, no adequate and well–controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. 8.2 Labor and Delivery Oral ampicillin-class antibacterials are poorly absorbed during labor. It is not known whether use of amoxicillin/clavulanate potassium in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention. 8.3 Nursing Mothers Amoxicillin has been shown to be excreted in human milk. Amoxicillin/clavulanate potassium use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin/clavulanate potassium is administered to a nursing woman. 8.4 Pediatric Use The safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension and amoxicillin and clavulanate potassium tablets (chewable) have been established in pediatric patients. Use of amoxicillin and clavulanate potassium for oral suspension and amoxicillin and clavulanate potassium tablets (chewable) in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media [ see Clinical Studies ( 14.2 ) ]. Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. Dosing of amoxicillin and clavulanate potassium for oral suspension and amoxicillin and clavulanate potassium tablets (chewable) should be modified in pediatric patients aged less than 12 weeks (less than 3 months) [ see Dosage and Administration ( 2.3 ) ]. 8.5 Geriatric Use Of the 3,119 patients in an analysis of clinical studies of amoxicillin/clavulanate potassium, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min). See Patients with Renal Impairment [see Dosage and Administration ( 2.4 )] for specific recommendations in patients with renal impairment.
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are antibacterial drugs [see Microbiology ( 12.4 )] .
Description
openFDA Drug Labeling11 DESCRIPTION Amoxicillin and clavulanate potassium tablets, USP; for oral suspension, USP; and chewable tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid). Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S•3H 2 O, and the molecular weight is 419.46. Chemically, amoxicillin is (2 S, 5 R, 6 R )-6-[( R )-(-)-2-Amino-2-( p hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as: Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus . It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is C 8 H 8 KNO 5 , and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ( Z )( 2R,5R )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as: Amoxicillin and Clavulanate Potassium Tablets, USP: • 250 mg/125 mg: Each tablet contains 250 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). • 500 mg/125 mg: Each tablet contains 500 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). • 875 mg/125 mg: Each tablet contains 875 mg of amoxicillin as the trihydrate, and 125 mg of clavulanic acid (equivalent to 149 mg of clavulanate potassium). Amoxicillin and Clavulanate Potassium for Oral Suspension, USP: • 200 mg/28.5 mg: Following constitution, each 5 mL of oral suspension contains 200 mg of amoxicillin as the trihydrate, and 28.5 mg of clavulanic acid (equivalent to 34 mg of clavulanate potassium). • 400 mg/57 mg: Following constitution, each 5 mL of oral suspension contains 400 mg of amoxicillin as the trihydrate, and 57 mg of clavulanic acid (equivalent to 68 mg of clavulanate potassium). Amoxicillin and Clavulanate Potassium Chewable Tablets, USP: • 200 mg/28.5 mg: Each chewable tablet contains 200 mg of amoxicillin as the trihydrate, and 28.5 mg of clavulanic acid (equivalent to 34 mg of clavulanate potassium). • 400 mg/57 mg: Each chewable tablet contains 400 mg of amoxicillin as the trihydrate, and 57 mg of clavulanic acid (equivalent to 68 mg of clavulanate potassium). Inactive Ingredients • Amoxicillin and Clavulanate Potassium Tablets – Colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide, triethyl citrate, ethylcellulose, cetyl alcohol and sodium lauryl sulfate. In addition, the 875 mg/125 mg tablet contains crospovidone. ∘ Each tablet of amoxicillin and clavulanate potassium contains 0.63 mEq potassium. • Amoxicillin and Clavulanate Potassium for Oral Suspension – Aspartame, colloidal silicon dioxide, hydroxypropyl methylcellulose, mannitol, orange flavoring, precipitated silicon dioxide, succinic acid, xanthan gum, and golden syrup flavoring (caramel) [see Warnings and Precautions ( 5.8 )]. ∘ Each 5 mL of reconstituted 200 mg/28.5 mg oral suspension of amoxicillin and clavulanate potassium contains 0.14 mEq potassium ∘ Each 5 mL of reconstituted 400 mg/57 mg oral suspension of amoxicillin and clavulanate potassium contains 0.29 mEq potassium • Amoxicillin and Clavulanate Potassium Chewable Tablets – Aspartame, banana flavoring, cherry flavoring, colloidal silicon dioxide, FD&C Red No. 40, magnesium stearate, mannitol, and sodium starch glycolate [ see Warnings and Precautions ( 5.8 )]. ∘ Each 200 mg/28.5 mg chewable tablet of amoxicillin and clavulanate potassium contains 0.14 mEq potassium ∘ Each 400 mg/57 mg chewable tablet of amoxicillin a …
Overdosage
openFDA Drug Labeling10 OVERDOSAGE In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms 1 . Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin and clavulanate potassium. Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin and clavulanate potassium overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin and clavulanate potassium crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium may be removed from circulation by hemodialysis [ see Dosage and Administration ( 2.4 ) ].
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING Tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 250 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule shaped, debossed GGN5 on one side and plain on the reverse side, and contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 0781-1874-31 bottle of 30 film coated tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg: Each film coated tablet, for oral administration, is white, oval-shaped, debossed GGN6 on one side and plain on the reverse side, and contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 0781-1831-20 bottle of 20 film coated tablets NDC 0781-1831-01 bottle of 100 film coated tablets NDC 0781-1831-13 Unit Dose (10 x 10) 100 film coated tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule-shaped, scored and debossed GGN7 on one side and scored on the reverse side, and contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 0781-1852-20 bottle of 20 film coated tablets NDC 0781-1852-01 bottle of 100 film coated tablets NDC 0781-1852-13 Unit Dose (4 x 25) 100 film coated tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. For Oral Suspension Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 200 mg/28.5 mg per 5 mL: as a dry, white powder. Each 5 mL of reconstituted orange-flavored suspension contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt. NDC 0781-6102-52 50 mL bottle NDC 0781-6102-57 75 mL bottle NDC 0781-6102-46 100 mL bottle Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 400 mg/57 mg per 5 mL: as a dry, white powder. Each 5 mL of reconstituted orange-flavored suspension contains 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. NDC 0781-6104-52 50 mL bottle NDC 0781-6104-57 75 mL bottle NDC 0781-6104-46 100 mL bottle Store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container; Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. KEEP OUT OF THE REACH OF CHILDREN.
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: AMOXICILLIN. 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 III | June 7, 2017 | Sandoz Inc | Subpotent Drug; Clavulanic Acid | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-0820-0 | 50090-0820 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-0820-0) | November 28, 2014 |
| 50090-0820-1 | 50090-0820 | A-S Medication Solutions | 21 TABLET, FILM COATED in 1 BOTTLE (50090-0820-1) | November 28, 2014 |
| 50090-0820-2 | 50090-0820 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-0820-2) | November 28, 2014 |
| 50090-0820-3 | 50090-0820 | A-S Medication Solutions | 15 TABLET, FILM COATED in 1 BOTTLE (50090-0820-3) | November 28, 2014 |
| 50090-0822-0 | 50090-0822 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-0822-0) | November 28, 2014 |
| 50090-0822-1 | 50090-0822 | A-S Medication Solutions | 10 TABLET, FILM COATED in 1 BOTTLE (50090-0822-1) | November 28, 2014 |
| 50090-0822-2 | 50090-0822 | A-S Medication Solutions | 14 TABLET, FILM COATED in 1 BOTTLE (50090-0822-2) | November 28, 2014 |
| 50090-0822-3 | 50090-0822 | A-S Medication Solutions | 28 TABLET, FILM COATED in 1 BOTTLE (50090-0822-3) | November 28, 2014 |
| 50090-1809-0 | 50090-1809 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-1809-0) | May 7, 2015 |
| 50090-1809-1 | 50090-1809 | A-S Medication Solutions | 10 TABLET, FILM COATED in 1 BOTTLE (50090-1809-1) | September 18, 2025 |
| 50090-1809-2 | 50090-1809 | A-S Medication Solutions | 14 TABLET, FILM COATED in 1 BOTTLE (50090-1809-2) | May 7, 2015 |
| 50090-1809-3 | 50090-1809 | A-S Medication Solutions | 28 TABLET, FILM COATED in 1 BOTTLE (50090-1809-3) | May 7, 2015 |
| 50090-4413-0 | 50090-4413 | A-S Medication Solutions | 48 BOTTLE in 1 CASE (50090-4413-0) / 20 TABLET, FILM COATED in 1 BOTTLE | July 16, 2019 |
| 50090-4413-1 | 50090-4413 | A-S Medication Solutions | 24 BOTTLE in 1 CASE (50090-4413-1) / 20 TABLET, FILM COATED in 1 BOTTLE | February 14, 2024 |
| 50090-6997-0 | 50090-6997 | A-S Medication Solutions | 14 TABLET, FILM COATED in 1 BOTTLE (50090-6997-0) | December 27, 2023 |
| 50090-7003-0 | 50090-7003 | A-S Medication Solutions | 14 TABLET, FILM COATED in 1 BOTTLE (50090-7003-0) | December 28, 2023 |
| 80425-0180-1 | 80425-0180 | Advanced Rx Pharmacy of Tennessee, LLC | 20 TABLET, FILM COATED in 1 BOTTLE (80425-0180-1) | March 1, 2017 |
| 80425-0180-2 | 80425-0180 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0180-2) | March 1, 2017 |
| 80425-0180-3 | 80425-0180 | Advanced Rx Pharmacy of Tennessee, LLC | 14 TABLET, FILM COATED in 1 BOTTLE (80425-0180-3) | February 2, 2025 |
| 80425-0279-1 | 80425-0279 | Advanced Rx Pharmacy of Tennessee, LLC | 20 TABLET, FILM COATED in 1 BOTTLE (80425-0279-1) | March 3, 2023 |
| 80425-0279-2 | 80425-0279 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0279-2) | March 3, 2023 |
| 80425-0279-3 | 80425-0279 | Advanced Rx Pharmacy of Tennessee, LLC | 14 TABLET, FILM COATED in 1 BOTTLE (80425-0279-3) | February 2, 2025 |
| 60687-781-94 | 60687-781 | American Health Packaging | 20 BLISTER PACK in 1 CARTON (60687-781-94) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-781-11) | July 26, 2024 |
| 60687-792-01 | 60687-792 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-792-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-792-11) | July 26, 2024 |
| 60687-803-01 | 60687-803 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-803-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-803-11) | July 26, 2024 |
| 76420-005-20 | 76420-005 | Asclemed USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (76420-005-20) | September 1, 2020 |
| 76420-501-20 | 76420-501 | Asclemed USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (76420-501-20) | May 1, 2020 |
| 76420-503-30 | 76420-503 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-503-30) | October 15, 2019 |
| 76420-507-20 | 76420-507 | Asclemed USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (76420-507-20) | October 15, 2019 |
| 76420-529-20 | 76420-529 | Asclemed USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (76420-529-20) | December 13, 2022 |
| 76420-607-01 | 76420-607 | Asclemed USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (76420-607-01) | September 6, 2023 |
| 76420-607-20 | 76420-607 | Asclemed USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (76420-607-20) | September 6, 2023 |
| 76420-608-20 | 76420-608 | Asclemed USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (76420-608-20) | September 6, 2023 |
| 65862-501-05 | 65862-501 | Aurobindo Pharma Limited | 500 TABLET, FILM COATED in 1 BOTTLE (65862-501-05) | January 20, 2012 |
| 65862-501-15 | 65862-501 | Aurobindo Pharma Limited | 1500 TABLET, FILM COATED in 1 BAG (65862-501-15) | January 20, 2012 |
| 65862-501-30 | 65862-501 | Aurobindo Pharma Limited | 30 TABLET, FILM COATED in 1 BOTTLE (65862-501-30) | January 20, 2012 |
| 65862-502-05 | 65862-502 | Aurobindo Pharma Limited | 500 TABLET, FILM COATED in 1 BOTTLE (65862-502-05) | January 20, 2012 |
| 65862-502-20 | 65862-502 | Aurobindo Pharma Limited | 20 TABLET, FILM COATED in 1 BOTTLE (65862-502-20) | January 20, 2012 |
| 65862-502-99 | 65862-502 | Aurobindo Pharma Limited | 1000 TABLET, FILM COATED in 1 BAG (65862-502-99) | January 20, 2012 |
| 65862-503-01 | 65862-503 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED in 1 BOTTLE (65862-503-01) | January 20, 2012 |
| 65862-503-20 | 65862-503 | Aurobindo Pharma Limited | 20 TABLET, FILM COATED in 1 BOTTLE (65862-503-20) | January 20, 2012 |
| 65862-503-82 | 65862-503 | Aurobindo Pharma Limited | 800 TABLET, FILM COATED in 1 BAG (65862-503-82) | January 20, 2012 |
| 63629-4541-1 | 63629-4541 | Bryant Ranch Prepack | 14 TABLET, FILM COATED in 1 BOTTLE (63629-4541-1) | November 7, 2024 |
| 63629-5847-1 | 63629-5847 | Bryant Ranch Prepack | 6 TABLET, FILM COATED in 1 BOTTLE (63629-5847-1) | May 29, 2025 |
| 71335-2735-1 | 71335-2735 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2735-1) | July 29, 2025 |
| 71335-2787-1 | 71335-2787 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2787-1) | March 12, 2026 |
| 71335-2824-1 | 71335-2824 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2824-1) | October 23, 2025 |
| 71335-2896-1 | 71335-2896 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2896-1) | October 23, 2025 |
| 71335-2917-1 | 71335-2917 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2917-1) | October 23, 2025 |
| 71335-2999-1 | 71335-2999 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2999-1) | November 5, 2025 |
| 71335-3138-1 | 71335-3138 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-3138-1) | May 27, 2026 |
| 72162-2210-2 | 72162-2210 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (72162-2210-2) | March 15, 2002 |
| 72162-2211-2 | 72162-2211 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (72162-2211-2) | March 14, 2002 |
| 72162-2433-1 | 72162-2433 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (72162-2433-1) | December 16, 2024 |
| 72162-2433-2 | 72162-2433 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (72162-2433-2) | December 16, 2024 |
| 72162-2434-1 | 72162-2434 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (72162-2434-1) | December 16, 2024 |
| 72162-2435-3 | 72162-2435 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (72162-2435-3) | December 16, 2024 |
| 67046-0366-3 | 67046-0366 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0366-3) | May 7, 2026 |
| 67046-0955-3 | 67046-0955 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0955-3) | May 4, 2026 |
| 73043-006-20 | 73043-006 | Devatis, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (73043-006-20) | November 1, 2024 |
| 73043-007-20 | 73043-007 | Devatis, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (73043-007-20) | November 1, 2024 |
| 72189-281-14 | 72189-281 | DirectRx | 14 TABLET, FILM COATED in 1 BOTTLE (72189-281-14) | October 7, 2021 |
| 72189-281-20 | 72189-281 | DirectRx | 20 TABLET, FILM COATED in 1 BOTTLE (72189-281-20) | October 7, 2021 |
| 45865-227-20 | 45865-227 | Medsource Pharmaceuticals | 20 TABLET, FILM COATED in 1 BOTTLE (45865-227-20) | November 8, 2022 |
| 45865-230-20 | 45865-230 | Medsource Pharmaceuticals | 20 TABLET, FILM COATED in 1 BOTTLE (45865-230-20) | November 30, 2023 |
| 42571-160-01 | 42571-160 | Micro Labs Limited | 100 TABLET, FILM COATED in 1 BOTTLE (42571-160-01) | March 1, 2017 |
| 42571-160-11 | 42571-160 | Micro Labs Limited | 10 BLISTER PACK in 1 CARTON (42571-160-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-160-32) | March 1, 2017 |
| 42571-160-30 | 42571-160 | Micro Labs Limited | 30 TABLET, FILM COATED in 1 BOTTLE (42571-160-30) | March 1, 2017 |
| 42571-161-01 | 42571-161 | Micro Labs Limited | 100 TABLET, FILM COATED in 1 BOTTLE (42571-161-01) | March 1, 2017 |
| 42571-161-11 | 42571-161 | Micro Labs Limited | 10 BLISTER PACK in 1 CARTON (42571-161-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-161-32) | March 1, 2017 |
| 42571-161-42 | 42571-161 | Micro Labs Limited | 20 TABLET, FILM COATED in 1 BOTTLE (42571-161-42) | March 1, 2017 |
| 42571-162-01 | 42571-162 | Micro Labs Limited | 100 TABLET, FILM COATED in 1 BOTTLE (42571-162-01) | March 1, 2017 |
| 42571-162-42 | 42571-162 | Micro Labs Limited | 20 TABLET, FILM COATED in 1 BOTTLE (42571-162-42) | March 1, 2017 |
| 42571-162-44 | 42571-162 | Micro Labs Limited | 4 BLISTER PACK in 1 CARTON (42571-162-44) / 4 TABLET, FILM COATED in 1 BLISTER PACK (42571-162-43) | March 1, 2017 |
| 16714-295-01 | 16714-295 | NorthStar Rx LLC | 30 TABLET, FILM COATED in 1 BOTTLE (16714-295-01) | January 20, 2012 |
| 16714-296-01 | 16714-296 | NorthStar Rx LLC | 20 TABLET, FILM COATED in 1 BOTTLE (16714-296-01) | January 20, 2012 |
| 16714-297-01 | 16714-297 | NorthStar Rx LLC | 20 TABLET, FILM COATED in 1 BOTTLE (16714-297-01) | January 20, 2012 |
| 16714-297-02 | 16714-297 | NorthStar Rx LLC | 100 TABLET, FILM COATED in 1 BOTTLE (16714-297-02) | January 20, 2012 |
| 82868-002-10 | 82868-002 | Northwind Health Company, LLC | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-002-10) | September 26, 2023 |
| 82868-002-14 | 82868-002 | Northwind Health Company, LLC | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-002-14) | June 21, 2024 |
| 82868-067-14 | 82868-067 | Northwind Health Company, LLC | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-067-14) | October 17, 2024 |
| 68071-2751-2 | 68071-2751 | NuCare Pharmaceutials,Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68071-2751-2) | June 3, 2022 |
| 68071-3822-3 | 68071-3822 | NuCare Pharmaceuticals, Inc. | 3 TABLET, FILM COATED in 1 BOTTLE (68071-3822-3) | April 2, 2025 |
| 68071-3842-2 | 68071-3842 | NuCare Pharmaceuticals, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68071-3842-2) | May 7, 2025 |
| 68071-3860-2 | 68071-3860 | NuCare Pharmaceuticals, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68071-3860-2) | June 5, 2025 |
| 68071-3866-3 | 68071-3866 | NuCare Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3866-3) | June 13, 2025 |
| 68071-5295-2 | 68071-5295 | NuCare Pharmaceuticals, Inc. | 2 TABLET, FILM COATED in 1 BOTTLE (68071-5295-2) | September 16, 2026 |
| 68071-5295-3 | 68071-5295 | NuCare Pharmaceuticals, Inc. | 3 TABLET, FILM COATED in 1 BOTTLE (68071-5295-3) | June 3, 2026 |
| 68071-5295-4 | 68071-5295 | NuCare Pharmaceuticals, Inc. | 4 TABLET, FILM COATED in 1 BOTTLE (68071-5295-4) | June 3, 2026 |
| 68071-2896-2 | 68071-2896 | NuCare Pharmaceuticals,Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68071-2896-2) | December 6, 2022 |
| 68071-2933-3 | 68071-2933 | NuCare Pharmaceuticals,Inc. | 3 TABLET, FILM COATED in 1 BOTTLE (68071-2933-3) | February 8, 2023 |
| 68071-2982-2 | 68071-2982 | NuCare Pharmaceuticals,Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68071-2982-2) | April 19, 2023 |
| 68071-3402-1 | 68071-3402 | NuCare Pharmaceuticals,Inc. | 10 TABLET, FILM COATED in 1 BOTTLE (68071-3402-1) | June 21, 2023 |
| 68071-3402-3 | 68071-3402 | NuCare Pharmaceuticals,Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3402-3) | May 16, 2023 |
| 68071-3402-4 | 68071-3402 | NuCare Pharmaceuticals,Inc. | 14 TABLET, FILM COATED in 1 BOTTLE (68071-3402-4) | May 16, 2023 |
| 68071-3402-6 | 68071-3402 | NuCare Pharmaceuticals,Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68071-3402-6) | June 21, 2023 |
| 68071-3402-8 | 68071-3402 | NuCare Pharmaceuticals,Inc. | 28 TABLET, FILM COATED in 1 BOTTLE (68071-3402-8) | June 21, 2023 |
| 68071-3864-4 | 68071-3864 | NuCare Pharmaceuticals,Inc. | 14 TABLET, FILM COATED in 1 BOTTLE (68071-3864-4) | June 6, 2025 |
| 68071-3947-3 | 68071-3947 | NuCare Pharmaceuticals,Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3947-3) | January 12, 2026 |
| 68071-4224-2 | 68071-4224 | NuCare Pharmaceuticals,Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68071-4224-2) | January 11, 2018 |
| 68071-4275-2 | 68071-4275 | NuCare Pharmaceuticals,Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68071-4275-2) | February 7, 2018 |
| 68071-4284-3 | 68071-4284 | NuCare Pharmaceuticals,Inc. | 3 TABLET, FILM COATED in 1 BOTTLE (68071-4284-3) | February 15, 2018 |
| 68071-4284-4 | 68071-4284 | NuCare Pharmaceuticals,Inc. | 4 TABLET, FILM COATED in 1 BOTTLE (68071-4284-4) | February 15, 2018 |
| 68071-4300-1 | 68071-4300 | NuCare Pharmaceuticals,Inc. | 21 TABLET, FILM COATED in 1 BOTTLE (68071-4300-1) | February 27, 2018 |
| 68071-4300-3 | 68071-4300 | NuCare Pharmaceuticals,Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68071-4300-3) | February 27, 2018 |
| 68071-4300-4 | 68071-4300 | NuCare Pharmaceuticals,Inc. | 14 TABLET, FILM COATED in 1 BOTTLE (68071-4300-4) | February 27, 2018 |
| 68071-4300-6 | 68071-4300 | NuCare Pharmaceuticals,Inc. | 6 TABLET, FILM COATED in 1 BOTTLE (68071-4300-6) | February 27, 2018 |
| 68071-4549-3 | 68071-4549 | NuCare Pharmaceuticals,Inc. | 3 TABLET, FILM COATED in 1 BOTTLE (68071-4549-3) | September 5, 2018 |
| 68071-4549-4 | 68071-4549 | NuCare Pharmaceuticals,Inc. | 4 TABLET, FILM COATED in 1 BOTTLE (68071-4549-4) | September 5, 2018 |
| 68071-4549-6 | 68071-4549 | NuCare Pharmaceuticals,Inc. | 6 TABLET, FILM COATED in 1 BOTTLE (68071-4549-6) | September 5, 2018 |
| 68071-4586-3 | 68071-4586 | NuCare Pharmaceuticals,Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68071-4586-3) | October 4, 2018 |
| 68071-4586-4 | 68071-4586 | NuCare Pharmaceuticals,Inc. | 14 TABLET, FILM COATED in 1 BOTTLE (68071-4586-4) | October 4, 2018 |
| 68071-4586-6 | 68071-4586 | NuCare Pharmaceuticals,Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68071-4586-6) | September 22, 2023 |
| 68071-5065-2 | 68071-5065 | NuCare Pharmaceuticals,Inc. | 2 TABLET, FILM COATED in 1 BOTTLE (68071-5065-2) | June 18, 2026 |
| 68071-5065-3 | 68071-5065 | NuCare Pharmaceuticals,Inc. | 3 TABLET, FILM COATED in 1 BOTTLE (68071-5065-3) | September 20, 2019 |
| 68071-5065-4 | 68071-5065 | NuCare Pharmaceuticals,Inc. | 4 TABLET, FILM COATED in 1 BOTTLE (68071-5065-4) | September 20, 2019 |
| 43063-077-03 | 43063-077 | PD-Rx Pharmaceuticals, Inc. | 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-03) | February 26, 2009 |
| 43063-077-04 | 43063-077 | PD-Rx Pharmaceuticals, Inc. | 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-04) | February 26, 2009 |
| 43063-077-06 | 43063-077 | PD-Rx Pharmaceuticals, Inc. | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-077-06) | February 26, 2009 |
| 43063-377-02 | 43063-377 | PD-Rx Pharmaceuticals, Inc. | 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-377-02) | August 3, 2012 |
| 55289-767-10 | 55289-767 | PD-Rx Pharmaceuticals, Inc. | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-10) | January 25, 2011 |
| 55289-767-14 | 55289-767 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-14) | January 25, 2011 |
| 55289-767-20 | 55289-767 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-20) | January 25, 2011 |
| 55289-767-21 | 55289-767 | PD-Rx Pharmaceuticals, Inc. | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-21) | January 25, 2011 |
| 55289-767-28 | 55289-767 | PD-Rx Pharmaceuticals, Inc. | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-28) | January 25, 2011 |
| 55289-767-30 | 55289-767 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-767-30) | January 25, 2011 |
| 55289-845-06 | 55289-845 | PD-Rx Pharmaceuticals, Inc. | 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-06) | December 6, 2012 |
| 55289-845-20 | 55289-845 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-20) | December 6, 2012 |
| 55289-845-21 | 55289-845 | PD-Rx Pharmaceuticals, Inc. | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-21) | December 6, 2012 |
| 55289-845-28 | 55289-845 | PD-Rx Pharmaceuticals, Inc. | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-28) | December 6, 2012 |
| 55289-845-30 | 55289-845 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-845-30) | December 6, 2012 |
| 72789-418-14 | 72789-418 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-418-14) | July 3, 2024 |
| 72789-456-14 | 72789-456 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-456-14) | December 11, 2024 |
| 72789-459-03 | 72789-459 | PD-Rx Pharmaceuticals, Inc. | 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-459-03) | August 13, 2026 |
| 72789-459-14 | 72789-459 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-459-14) | December 11, 2024 |
| 72789-533-21 | 72789-533 | PD-Rx Pharmaceuticals, Inc. | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-533-21) | October 15, 2025 |
| 72789-533-30 | 72789-533 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-533-30) | November 20, 2025 |
| 72789-585-28 | 72789-585 | PD-Rx Pharmaceuticals, Inc. | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-585-28) | July 31, 2026 |
| 72789-585-30 | 72789-585 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-585-30) | August 7, 2026 |
| 68788-4158-2 | 68788-4158 | Preferred Pharmaceuticals Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68788-4158-2) | July 16, 2026 |
| 68788-7531-2 | 68788-7531 | Preferred Pharmaceuticals Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68788-7531-2) | March 11, 2020 |
| 68788-7998-2 | 68788-7998 | Preferred Pharmaceuticals Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68788-7998-2) | August 10, 2021 |
| 68788-8317-2 | 68788-8317 | Preferred Pharmaceuticals Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8317-2) | December 23, 2022 |
| 68788-8836-2 | 68788-8836 | Preferred Pharmaceuticals Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8836-2) | February 27, 2025 |
| 63187-014-14 | 63187-014 | Proficient Rx LP | 14 TABLET, FILM COATED in 1 BOTTLE (63187-014-14) | September 27, 2022 |
| 63187-014-20 | 63187-014 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (63187-014-20) | May 1, 2014 |
| 63187-032-06 | 63187-032 | Proficient Rx LP | 6 TABLET, FILM COATED in 1 BOTTLE (63187-032-06) | December 28, 2020 |
| 63187-032-20 | 63187-032 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (63187-032-20) | May 1, 2014 |
| 63187-032-21 | 63187-032 | Proficient Rx LP | 21 TABLET, FILM COATED in 1 BOTTLE (63187-032-21) | December 28, 2020 |
| 63187-327-20 | 63187-327 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (63187-327-20) | May 1, 2014 |
| 63187-488-14 | 63187-488 | Proficient Rx LP | 14 TABLET, FILM COATED in 1 BOTTLE (63187-488-14) | September 16, 2021 |
| 63187-488-20 | 63187-488 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (63187-488-20) | February 2, 2015 |
| 63187-488-28 | 63187-488 | Proficient Rx LP | 28 TABLET, FILM COATED in 1 BOTTLE (63187-488-28) | February 2, 2015 |
| 63187-488-30 | 63187-488 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (63187-488-30) | February 2, 2015 |
| 63187-488-40 | 63187-488 | Proficient Rx LP | 40 TABLET, FILM COATED in 1 BOTTLE (63187-488-40) | February 2, 2015 |
| 63187-803-20 | 63187-803 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (63187-803-20) | January 2, 2017 |
| 71205-014-06 | 71205-014 | Proficient Rx LP | 6 TABLET, FILM COATED in 1 BOTTLE (71205-014-06) | June 11, 2021 |
| 71205-014-20 | 71205-014 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (71205-014-20) | March 1, 2017 |
| 71205-014-21 | 71205-014 | Proficient Rx LP | 21 TABLET, FILM COATED in 1 BOTTLE (71205-014-21) | February 16, 2021 |
| 71205-331-14 | 71205-331 | Proficient Rx LP | 14 TABLET, FILM COATED in 1 BOTTLE (71205-331-14) | May 5, 2020 |
| 71205-331-15 | 71205-331 | Proficient Rx LP | 15 TABLET, FILM COATED in 1 BOTTLE (71205-331-15) | October 1, 2019 |
| 71205-331-20 | 71205-331 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (71205-331-20) | October 1, 2019 |
| 71205-331-30 | 71205-331 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (71205-331-30) | October 1, 2019 |
| 71205-331-60 | 71205-331 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE (71205-331-60) | October 1, 2019 |
| 71205-331-90 | 71205-331 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE (71205-331-90) | October 1, 2019 |
| 71205-651-10 | 71205-651 | Proficient Rx LP | 10 TABLET, FILM COATED in 1 BOTTLE (71205-651-10) | April 21, 2022 |
| 71205-651-20 | 71205-651 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (71205-651-20) | April 21, 2022 |
| 71205-651-30 | 71205-651 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (71205-651-30) | April 21, 2022 |
| 71205-651-60 | 71205-651 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE (71205-651-60) | April 21, 2022 |
| 71205-651-90 | 71205-651 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE (71205-651-90) | April 21, 2022 |
| 71205-712-10 | 71205-712 | Proficient Rx LP | 10 TABLET, FILM COATED in 1 BOTTLE (71205-712-10) | November 15, 2022 |
| 71205-712-14 | 71205-712 | Proficient Rx LP | 14 TABLET, FILM COATED in 1 BOTTLE (71205-712-14) | November 15, 2022 |
| 71205-712-20 | 71205-712 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (71205-712-20) | November 15, 2022 |
| 71205-712-21 | 71205-712 | Proficient Rx LP | 21 TABLET, FILM COATED in 1 BOTTLE (71205-712-21) | November 15, 2022 |
| 71205-712-28 | 71205-712 | Proficient Rx LP | 28 TABLET, FILM COATED in 1 BOTTLE (71205-712-28) | November 15, 2022 |
| 71205-712-30 | 71205-712 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (71205-712-30) | November 15, 2022 |
| 71205-712-60 | 71205-712 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE (71205-712-60) | November 15, 2022 |
| 71205-712-90 | 71205-712 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE (71205-712-90) | November 15, 2022 |
| 82804-201-20 | 82804-201 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (82804-201-20) | March 20, 2025 |
| 70518-2225-0 | 70518-2225 | REMEDYREPACK INC. | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2225-0) | July 19, 2019 |
| 70518-2225-1 | 70518-2225 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2225-1) | June 10, 2020 |
| 70518-2225-2 | 70518-2225 | REMEDYREPACK INC. | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2225-2) | June 17, 2020 |
| 70518-2225-4 | 70518-2225 | REMEDYREPACK INC. | 14 TABLET, FILM COATED in 1 BLISTER PACK (70518-2225-4) | September 30, 2020 |
| 70518-2225-5 | 70518-2225 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2225-5) | April 6, 2021 |
| 70518-2225-6 | 70518-2225 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-2225-6) / 1 TABLET, FILM COATED in 1 POUCH (70518-2225-7) | October 11, 2021 |
| 70518-2225-8 | 70518-2225 | REMEDYREPACK INC. | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2225-8) | December 7, 2021 |
| 70518-2263-0 | 70518-2263 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-0) | August 12, 2019 |
| 70518-2263-1 | 70518-2263 | REMEDYREPACK INC. | 20 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-1) | August 12, 2019 |
| 70518-2263-2 | 70518-2263 | REMEDYREPACK INC. | 14 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-2) | December 12, 2019 |
| 70518-2263-3 | 70518-2263 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-2263-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-2263-4) | November 17, 2021 |
| 70518-2263-7 | 70518-2263 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-7) | September 14, 2022 |
| 70518-2263-8 | 70518-2263 | REMEDYREPACK INC. | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2263-8) | March 14, 2023 |
| 70518-2263-9 | 70518-2263 | REMEDYREPACK INC. | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2263-9) | April 4, 2023 |
| 70518-2625-2 | 70518-2625 | REMEDYREPACK INC. | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2625-2) | December 28, 2021 |
| 70518-2625-3 | 70518-2625 | REMEDYREPACK INC. | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2625-3) | March 30, 2022 |
| 70518-2625-4 | 70518-2625 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2625-4) | January 17, 2023 |
| 70518-2625-6 | 70518-2625 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-2625-6) / 1 TABLET, FILM COATED in 1 POUCH (70518-2625-7) | July 15, 2026 |
| 70518-3604-3 | 70518-3604 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3604-3) | June 3, 2026 |
| 70518-3604-4 | 70518-3604 | REMEDYREPACK INC. | 20 TABLET, FILM COATED in 1 BLISTER PACK (70518-3604-4) | June 25, 2026 |
| 70518-3624-2 | 70518-3624 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3624-2) | February 12, 2025 |
| 70518-3624-4 | 70518-3624 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-3624-4) / 1 TABLET, FILM COATED in 1 POUCH (70518-3624-5) | December 23, 2025 |
| 70518-3676-2 | 70518-3676 | REMEDYREPACK INC. | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3676-2) | June 18, 2025 |
| 70518-3967-1 | 70518-3967 | REMEDYREPACK INC. | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3967-1) | February 6, 2026 |
| 70518-3967-2 | 70518-3967 | REMEDYREPACK INC. | 50 POUCH in 1 BOX (70518-3967-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-3967-3) | June 19, 2026 |
| 70518-4424-0 | 70518-4424 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4424-0) | August 5, 2025 |
| 0781-1831-01 | 0781-1831 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOTTLE (0781-1831-01) | September 20, 2022 |
| 0781-1831-13 | 0781-1831 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0781-1831-13) | March 15, 2002 |
| 0781-1831-20 | 0781-1831 | Sandoz Inc | 20 TABLET, FILM COATED in 1 BOTTLE (0781-1831-20) | March 15, 2002 |
| 0781-1852-01 | 0781-1852 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOTTLE (0781-1852-01) | September 20, 2022 |
| 0781-1852-13 | 0781-1852 | Sandoz Inc | 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0781-1852-13) | March 14, 2002 |
| 0781-1852-20 | 0781-1852 | Sandoz Inc | 20 TABLET, FILM COATED in 1 BOTTLE (0781-1852-20) | March 14, 2002 |
| 0781-1874-31 | 0781-1874 | Sandoz Inc | 30 TABLET, FILM COATED in 1 BOTTLE (0781-1874-31) | August 23, 2005 |
| 85766-019-01 | 85766-019 | Sportpharm LLC | 100 TABLET, FILM COATED in 1 BOTTLE (85766-019-01) | February 3, 2026 |
| 85766-019-20 | 85766-019 | Sportpharm LLC | 20 TABLET, FILM COATED in 1 BOTTLE (85766-019-20) | August 13, 2025 |
| 85766-022-20 | 85766-022 | Sportpharm LLC | 20 TABLET, FILM COATED in 1 BOTTLE (85766-022-20) | August 13, 2025 |
| 85766-078-01 | 85766-078 | Sportpharm LLC | 100 TABLET, FILM COATED in 1 BOTTLE (85766-078-01) | October 15, 2025 |
| 85766-078-20 | 85766-078 | Sportpharm LLC | 20 TABLET, FILM COATED in 1 BOTTLE (85766-078-20) | October 15, 2025 |
| 85766-079-20 | 85766-079 | Sportpharm LLC | 20 TABLET, FILM COATED in 1 BOTTLE (85766-079-20) | October 15, 2025 |
| 85766-080-30 | 85766-080 | Sportpharm LLC | 30 TABLET, FILM COATED in 1 BOTTLE (85766-080-30) | October 15, 2025 |
| 85766-171-14 | 85766-171 | Sportpharm LLC | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-171-14) | February 20, 2026 |
| 85766-268-01 | 85766-268 | Sportpharm LLC | 100 POUCH in 1 BOX (85766-268-01) / 1 TABLET, FILM COATED in 1 POUCH | August 29, 2026 |
| 85766-268-03 | 85766-268 | Sportpharm LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (85766-268-03) | August 29, 2026 |
| 85766-268-10 | 85766-268 | Sportpharm LLC | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-268-10) | August 29, 2026 |
| 85766-268-14 | 85766-268 | Sportpharm LLC | 14 TABLET, FILM COATED in 1 BLISTER PACK (85766-268-14) | August 29, 2026 |
| 85766-268-20 | 85766-268 | Sportpharm LLC | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-268-20) | August 29, 2026 |
| 85766-268-30 | 85766-268 | Sportpharm LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (85766-268-30) | August 29, 2026 |
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| 0093-2275-34 | 0093-2275 | Teva Pharmaceuticals USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (0093-2275-34) | October 31, 2002 |
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| 72189-281 | 72189-281 | DirectRx | — | October 7, 2021 |
| 45865-227 | 45865-227 | Medsource Pharmaceuticals | — | March 1, 2017 |
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| 42571-160 | 42571-160 | Micro Labs Limited | — | March 1, 2017 |
| 42571-161 | 42571-161 | Micro Labs Limited | — | March 1, 2017 |
| 42571-162 | 42571-162 | Micro Labs Limited | — | March 1, 2017 |
| 16714-295 | 16714-295 | NorthStar Rx LLC | — | January 20, 2012 |
| 16714-296 | 16714-296 | NorthStar Rx LLC | — | January 20, 2012 |
| 16714-297 | 16714-297 | NorthStar Rx LLC | — | January 20, 2012 |
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| 68071-3402 | 68071-3402 | NuCare Pharmaceuticals,Inc. | — | March 1, 2017 |
| 68071-3864 | 68071-3864 | NuCare Pharmaceuticals,Inc. | — | January 20, 2012 |
| 68071-3947 | 68071-3947 | NuCare Pharmaceuticals,Inc. | — | January 20, 2012 |
| 68071-4224 | 68071-4224 | NuCare Pharmaceuticals,Inc. | — | March 1, 2017 |
| 68071-4275 | 68071-4275 | NuCare Pharmaceuticals,Inc. | — | March 1, 2017 |
| 68071-4284 | 68071-4284 | NuCare Pharmaceuticals,Inc. | — | March 1, 2017 |
| 68071-4300 | 68071-4300 | NuCare Pharmaceuticals,Inc. | — | March 1, 2017 |
| 68071-4549 | 68071-4549 | NuCare Pharmaceuticals,Inc. | — | March 1, 2017 |
| 68071-4586 | 68071-4586 | NuCare Pharmaceuticals,Inc. | — | January 20, 2012 |
| 68071-5065 | 68071-5065 | NuCare Pharmaceuticals,Inc. | — | January 20, 2012 |
| 43063-077 | 43063-077 | PD-Rx Pharmaceuticals, Inc. | — | October 31, 2002 |
| 43063-377 | 43063-377 | PD-Rx Pharmaceuticals, Inc. | — | October 31, 2002 |
| 55289-767 | 55289-767 | PD-Rx Pharmaceuticals, Inc. | — | October 31, 2002 |
| 55289-845 | 55289-845 | PD-Rx Pharmaceuticals, Inc. | — | October 31, 2002 |
| 72789-418 | 72789-418 | PD-Rx Pharmaceuticals, Inc. | — | October 31, 2002 |
| 72789-456 | 72789-456 | PD-Rx Pharmaceuticals, Inc. | — | January 20, 2012 |
| 72789-459 | 72789-459 | PD-Rx Pharmaceuticals, Inc. | — | January 20, 2012 |
| 72789-533 | 72789-533 | PD-Rx Pharmaceuticals, Inc. | — | January 20, 2012 |
| 72789-585 | 72789-585 | PD-Rx Pharmaceuticals, Inc. | — | January 20, 2012 |
| 68788-4158 | 68788-4158 | Preferred Pharmaceuticals Inc. | — | October 31, 2002 |
| 68788-7531 | 68788-7531 | Preferred Pharmaceuticals Inc. | — | March 11, 2020 |
| 68788-7998 | 68788-7998 | Preferred Pharmaceuticals Inc. | — | August 10, 2021 |
| 68788-8317 | 68788-8317 | Preferred Pharmaceuticals Inc. | — | December 23, 2022 |
| 68788-8836 | 68788-8836 | Preferred Pharmaceuticals Inc. | — | February 27, 2025 |
| 63187-014 | 63187-014 | Proficient Rx LP | — | January 20, 2012 |
| 63187-032 | 63187-032 | Proficient Rx LP | — | October 31, 2002 |
| 63187-327 | 63187-327 | Proficient Rx LP | — | October 31, 2002 |
| 63187-488 | 63187-488 | Proficient Rx LP | — | March 14, 2002 |
| 63187-803 | 63187-803 | Proficient Rx LP | — | March 15, 2002 |
| 71205-014 | 71205-014 | Proficient Rx LP | — | March 1, 2017 |
| 71205-331 | 71205-331 | Proficient Rx LP | — | March 1, 2017 |
| 71205-651 | 71205-651 | Proficient Rx LP | — | May 1, 2020 |
| 71205-712 | 71205-712 | Proficient Rx LP | — | May 1, 2020 |
| 82804-201 | 82804-201 | Proficient Rx LP | — | January 20, 2012 |
| 70518-2225 | 70518-2225 | REMEDYREPACK INC. | — | July 19, 2019 |
| 70518-2263 | 70518-2263 | REMEDYREPACK INC. | — | August 12, 2019 |
| 70518-2625 | 70518-2625 | REMEDYREPACK INC. | — | March 13, 2020 |
| 70518-3604 | 70518-3604 | REMEDYREPACK INC. | — | January 4, 2023 |
| 70518-3624 | 70518-3624 | REMEDYREPACK INC. | — | January 27, 2023 |
| 70518-3676 | 70518-3676 | REMEDYREPACK INC. | — | March 15, 2023 |
| 70518-3967 | 70518-3967 | REMEDYREPACK INC. | — | December 19, 2023 |
| 70518-4424 | 70518-4424 | REMEDYREPACK INC. | — | August 5, 2025 |
| 0781-1831 | 0781-1831 | Sandoz Inc | — | March 15, 2002 |
| 0781-1852 | 0781-1852 | Sandoz Inc | — | March 14, 2002 |
| 0781-1874 | 0781-1874 | Sandoz Inc | — | August 23, 2005 |
| 85766-019 | 85766-019 | Sportpharm LLC | — | January 20, 2012 |
| 85766-022 | 85766-022 | Sportpharm LLC | — | January 20, 2012 |
| 85766-078 | 85766-078 | Sportpharm LLC | — | January 20, 2012 |
| 85766-079 | 85766-079 | Sportpharm LLC | — | January 20, 2012 |
| 85766-080 | 85766-080 | Sportpharm LLC | — | January 20, 2012 |
| 85766-171 | 85766-171 | Sportpharm LLC | — | August 12, 2019 |
| 85766-268 | 85766-268 | Sportpharm LLC | — | July 19, 2019 |
| 0093-2274 | 0093-2274 | Teva Pharmaceuticals USA, Inc. | — | October 31, 2002 |
| 0093-2275 | 0093-2275 | Teva Pharmaceuticals USA, Inc. | — | October 31, 2002 |
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.