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Medroxyprogesterone Acetate
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 |
|---|---|---|
| Progesterone Congeners [CS] | CS | All 40 members |
| Progestin [EPC] | EPC | All 40 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 040159-001 | MEDROXYPROGESTERONE ACETATE | TABLET | MEDROXYPROGESTERONE ACETATE | Prescription | AB | ||
| 040159-002 | MEDROXYPROGESTERONE ACETATE | TABLET | MEDROXYPROGESTERONE ACETATE | Prescription | AB | ||
| 040159-003 | MEDROXYPROGESTERONE ACETATE | TABLET | MEDROXYPROGESTERONE ACETATE | 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 | 34 | Labeling | Approved | September 16, 2024 | Standard |
| Supplement | 29 | Labeling | Approved | June 7, 2021 | Standard |
| Supplement | 23 | Labeling | Approved | December 26, 2007 | — |
| Supplement | 21 | Manufacturing (CMC) | Approved | April 10, 2002 | — |
| Supplement | 19 | Manufacturing (CMC) | Approved | December 14, 2001 | — |
| Supplement | 20 | Labeling | Approved | October 26, 2001 | — |
| Supplement | 18 | Manufacturing (CMC) | Approved | May 16, 2000 | — |
| Supplement | 15 | Manufacturing (CMC) | Approved | January 24, 2000 | — |
| Supplement | 16 | Manufacturing (CMC) | Approved | December 21, 1999 | — |
| Supplement | 17 | Labeling | Approved | September 24, 1999 | — |
| Supplement | 14 | Labeling | Approved | July 7, 1999 | — |
| Supplement | 13 | Manufacturing (CMC) | Approved | May 20, 1999 | — |
| Supplement | 12 | Labeling | Approved | March 26, 1999 | — |
| Supplement | 11 | Manufacturing (CMC) | Approved | March 26, 1999 | — |
| Supplement | 7 | Manufacturing (CMC) | Approved | March 11, 1999 | — |
| Supplement | 9 | Manufacturing (CMC) | Approved | February 5, 1999 | — |
| Supplement | 8 | Manufacturing (CMC) | Approved | December 1, 1998 | — |
| Supplement | 6 | Manufacturing (CMC) | Approved | September 25, 1998 | — |
| Supplement | 5 | Manufacturing (CMC) | Approved | September 25, 1998 | — |
| Supplement | 1 | Manufacturing (CMC) | Approved | December 27, 1996 | — |
| Original application | 1 | Approved | August 9, 1996 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260720). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. ( See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders and Probable Dementia . ) The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. ( See CLINICAL STUDIES and WARNINGS, Cardiovascular Disorders . ) The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women. (See CLINICAL STUDIES and WARNINGS , Probable Dementia and PRECAUTIONS , Geriatric Use . ) Breast Cancer The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer. (See CLINICAL STUDIES and WARNINGS , Malignant Neoplasm , Breast Cancer . ) In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins. Progestins with estrogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
What is the most important information I should know about medroxyprogesterone acetate (a progestin hormone)? • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes, or dementia (decline in brain function). • Using estrogens with progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women age 65 years or older. • You and your healthcare provider should talk regularly about whether you still need treatment with medroxyprogesterone acetate.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Medroxyprogesterone acetate tablets, USP are indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as fibroids or uterine cancer. They are also indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving daily oral conjugated estrogens 0.625 mg tablets.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Secondary Amenorrhea Medroxyprogesterone acetate tablets may be given in dosages of 5 or 10 mg daily for 5 to 10 days. A dose for inducing an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen is 10 mg of medroxyprogesterone acetate daily for 10 days. In cases of secondary amenorrhea, therapy may be started at any time. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing medroxyprogesterone acetate therapy. Abnormal Uterine Bleeding Due to Hormonal Imbalance in the Absence of Organic Pathology Beginning on the calculated 16th or 21st day of the menstrual cycle, 5 or 10 mg of medroxyprogesterone acetate may be given daily for 5 to 10 days. To produce an optimum secretory transformation of an endometrium that has been adequately primed with either endogenous or exogenous estrogen, 10 mg of medroxyprogesterone acetate daily for 10 days beginning on the 16th day of the cycle is suggested. Progestin withdrawal bleeding usually occurs within three to seven days after discontinuing therapy with medroxyprogesterone acetate. Patients with a past history of recurrent episodes of abnormal uterine bleeding may benefit from planned menstrual cycling with medroxyprogesterone acetate. Reduction of Endometrial Hyperplasia in Postmenopausal Women Receiving Daily 0.625 mg Conjugated Estrogens When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be re-evaluated periodically as clinically appropriate (for example, 3 to 6 month intervals) to determine if treatment is still necessary (see Error! Hyperlink reference not valid. ). For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding. Medroxyprogesterone acetate tablets may be given in dosages of 5 or 10 mg daily for 12 to 14 consecutive days per month, in postmenopausal women receiving daily 0.625 mg conjugated estrogens, either beginning on the 1st day of the cycle or the 16th day of the cycle. Patients should be started at the lowest dose. The lowest effective dose of medroxyprogesterone acetate has not been determined.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Medroxyprogesterone acetate is contraindicated in women with any of the following conditions: 1. Undiagnosed abnormal genital bleeding. 2. Known, suspected, or history of breast cancer. 3. Known or suspected estrogen- or progesterone-dependent neoplasia. 4. Active DVT, PE, or a history of these conditions 5. Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. 6. Known anaphylactic reaction or angioedema to medroxyprogesterone acetate. 7. Known liver impairment or disease. 8. Known or suspected pregnancy.
Warnings
openFDA Drug LabelingWARNINGS See BOXED WARNINGS . 1. Cardiovascular Disorders. An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy. Should any of these events occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. a. Stroke In the WHI estrogen plus progestin substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving CE (0.625 mg) plus MPA (2.5 mg) compared to women in the same age group receiving placebo (33 versus 25 per 10,000 women-years) (see CLINICAL STUDIES . ) The increase in risk was demonstrated after the first year and persisted. Should a stroke occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. b. Coronary Heart Disease In the WHI estrogen plus progestin substudy, there was a statistically non-significant increased risk of CHD events reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (41 versus 34 per 10,000 women-years). An increase in relative risk was demonstrated in year 1, and a trend toward decreasing relative risk was reported in years 2 through 5. In postmenopausal women with documented heart disease (n = 2,763, average 66.7 years of age), in a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement Study [HERS]), treatment with daily CE (0.625 mg) plus MPA (2.5 mg) demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE plus MPA did not reduce the overall rate of CHD events in postmenopausal women with established coronary heart disease. There were more CHD events in the CE plus MPA-treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand three hundred and twenty-one (2,321) women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II. Average follow-up in HERS II was an additional 2.7 years, for a total of 6.8 years overall. Rates of CHD events were comparable among women in the CE plus MPA group and the placebo group in HERS, HERS II, and overall. c. Venous Thromboembolism In the WHI estrogen plus progestin substudy, a statistically significant 2-fold greater rate of VTE (DVT and PE) was reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (35 versus 17 per 10,000 women-years). Statistically significant increases in risk for both DVT (26 versus 13 per 10,000 women-years) and PE (18 versus 8 per 10,000 women-years) were also demonstrated. The increase in VTE risk was demonstrated during the first year and persisted (see CLINICAL STUDIES ). Should a VTE occur or be suspected, estrogen plus progestin therapy should be discontinued immediately. If feasible, estrogens plus progestins should be discontinued at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization. 2. Malignant Neoplasms a. Breast Cancer The most important randomized clinical trial providing information about breast cancer in estrogen plus progestin users is the WHI substudy of daily CE (0.625 mg) plus MPA (2.5 mg). After a mean follow-up of 5.6 years, the estrogen plus progestin substudy reported an increased risk of invasive breast cancer in women who took daily CE plus MPA. In this substudy, prior use of estrogen-alone or estrogen plus progestin therapy was reported by 26 percent of the women. The relative risk of invasive breast cancer was 1.24, and the absolute risk was 41 versus 33 cases per 10,000 women- …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS See BOXED WARNINGS , WARNINGS , and PRECAUTIONS . 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 following adverse reactions have been reported in women taking medroxyprogesterone acetate tablets, without concomitant estrogens treatment: 1. Genitourinary system Abnormal uterine bleeding (irregular, increase, decrease), change in menstrual flow, breakthrough bleeding, spotting, amenorrhea, changes in cervical erosion and cervical secretions. 2. Breasts Breast tenderness, mastodynia or galactorrhea has been reported. 3. Cardiovascular Thromboembolic disorders including thrombophlebitis and pulmonary embolism have been reported. 4. Gastrointestinal Nausea, cholestatic jaundice. 5. Skin Sensitivity reactions consisting of urticaria, pruritus, edema and generalized rash have occurred. Acne, alopecia and hirsutism have been reported. 6. Eyes Neuro-ocular lesions, for example, retinal thrombosis, and optic neuritis. 7. Central nervous system Mental depression, insomnia, somnolence, dizziness, headache, nervousness. 8. Miscellaneous Hypersensitivity reactions (for example, anaphylaxis and anaphylactoid reactions, angioedema), rash (allergic) with and without pruritus, change in weight (increase or decrease), pyrexia, edema/fluid retention, fatigue, decreased glucose tolerance. The following adverse reactions have been reported with estrogen plus progestin therapy. 1. Genitourinary system Abnormal uterine bleeding/spotting, or flow; breakthrough bleeding; spotting; dysmenorrheal/pelvic pain; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer. 2. Breasts Tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer. 3. Cardiovascular Deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure. 4. Gastrointestinal Nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis; enlargement of hepatic hemangiomas. 5. Skin Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritus, rash. 6. Eyes Retinal vascular thrombosis, intolerance to contact lenses. 7. Central nervous system Headache; migraine; dizziness; mental depression; chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia. 8. Miscellaneous Increase or decrease in weight; reduced carbohydrate tolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides. To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch .
Description
openFDA Drug LabelingDESCRIPTION Medroxyprogesterone acetate tablets contain medroxyprogesterone acetate, which is a derivative of progesterone. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water. The chemical name for medroxyprogesterone acetate is pregn-4-ene-3, 20-dione, 17-(acetyloxy)-6-methyl-, (6α)-. The structural formula is: Each medroxyprogesterone acetate tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate and the following inactive ingredients: Calcium stearate, corn starch, lactose, mineral oil, sucrose and talc. The 2.5 mg tablets also contain: FD&C Yellow No. 6. The 5 mg tablets also contain: FD&C Blue No.2–Aluminum Lake. Chemical Structure
Overdosage
openFDA Drug LabelingOVERDOSAGE Overdosage of estrogen plus progestin therapy may cause nausea and vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of CE plus MPA together with institution of appropriate symptomatic care. To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Medroxyprogesterone acetate tablets, USP are available in the following strengths and package sizes: 2.5 mg tablets (White, round, scored, biconvex tablet. Debossed with 555/872 on the scored side and stylized b on the other side) Bottles of 100: NDC 0555-0872-02 Bottles of 500: NDC 0555-0872-04 5 mg tablets (White, round, scored, biconvex tablet. Debossed with 555/873 on the scored side and stylized b on the other side) Bottles of 100: NDC 0555-0873-02 Bottles of 500: NDC 0555-0873-04 10 mg tablets (White, round, scored, biconvex tablet. Debossed with 555/779 on the scored side and stylized b on the other side) Bottles of 100: NDC 0555-0779-02 Bottles of 500: NDC 0555-0779-04 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep this and all medications out of the reach of children. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. C 3/2024
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: MEDROXYPROGESTERONE ACETATE. 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.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-0166-0 | 50090-0166 | A-S Medication Solutions | 10 TABLET in 1 BOTTLE (50090-0166-0) | June 21, 2016 |
| 50090-0166-2 | 50090-0166 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-0166-2) | November 28, 2014 |
| 50090-0490-2 | 50090-0490 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-0490-2) | June 29, 2016 |
| 50090-0491-1 | 50090-0491 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-0491-1) | June 29, 2016 |
| 60687-105-21 | 60687-105 | American Health Packaging | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-105-21) / 1 TABLET in 1 BLISTER PACK (60687-105-11) | April 19, 2016 |
| 63629-2612-1 | 63629-2612 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (63629-2612-1) | June 13, 2011 |
| 63629-2612-2 | 63629-2612 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-2612-2) | August 17, 2007 |
| 63629-2612-3 | 63629-2612 | Bryant Ranch Prepack | 5 TABLET in 1 BOTTLE (63629-2612-3) | August 12, 2011 |
| 63629-2612-4 | 63629-2612 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (63629-2612-4) | June 14, 2016 |
| 63629-2612-5 | 63629-2612 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (63629-2612-5) | July 28, 2021 |
| 63629-2612-6 | 63629-2612 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (63629-2612-6) | July 8, 2024 |
| 63629-2612-7 | 63629-2612 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-2612-7) | October 9, 2017 |
| 63629-8824-1 | 63629-8824 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-8824-1) | December 4, 1996 |
| 63629-8825-1 | 63629-8825 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-8825-1) | December 4, 1996 |
| 63629-8826-1 | 63629-8826 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-8826-1) | December 4, 1996 |
| 67046-1480-3 | 67046-1480 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-1480-3) | January 30, 2025 |
| 59762-0055-1 | 59762-0055 | Mylan Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (59762-0055-1) | August 20, 2018 |
| 59762-0055-2 | 59762-0055 | Mylan Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (59762-0055-2) | November 2, 2020 |
| 59762-0056-1 | 59762-0056 | Mylan Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (59762-0056-1) | June 17, 2019 |
| 59762-0056-2 | 59762-0056 | Mylan Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (59762-0056-2) | March 23, 2020 |
| 59762-0058-1 | 59762-0058 | Mylan Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (59762-0058-1) | January 2, 2019 |
| 59762-0058-2 | 59762-0058 | Mylan Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (59762-0058-2) | May 11, 2020 |
| 51655-520-52 | 51655-520 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-520-52) | December 27, 2023 |
| 68071-4132-1 | 68071-4132 | NuCare Pharmaceuticals,Inc. | 10 TABLET in 1 BOTTLE (68071-4132-1) | October 27, 2017 |
| 68071-4132-3 | 68071-4132 | NuCare Pharmaceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-4132-3) | October 27, 2017 |
| 55289-160-05 | 55289-160 | PD-Rx Pharmaceuticals, Inc. | 5 TABLET in 1 BOTTLE, PLASTIC (55289-160-05) | January 18, 2011 |
| 55289-160-10 | 55289-160 | PD-Rx Pharmaceuticals, Inc. | 10 TABLET in 1 BOTTLE, PLASTIC (55289-160-10) | January 18, 2011 |
| 55289-160-30 | 55289-160 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (55289-160-30) | January 18, 2011 |
| 55289-160-50 | 55289-160 | PD-Rx Pharmaceuticals, Inc. | 50 TABLET in 1 BOTTLE, PLASTIC (55289-160-50) | January 18, 2011 |
| 72789-043-30 | 72789-043 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-043-30) | December 30, 2019 |
| 68788-8112-3 | 68788-8112 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8112-3) | December 6, 2021 |
| 68788-9899-1 | 68788-9899 | Preferred Pharmaceuticals, Inc. | 10 TABLET in 1 BOTTLE (68788-9899-1) | February 13, 2012 |
| 68788-9899-3 | 68788-9899 | Preferred Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68788-9899-3) | February 13, 2012 |
| 63187-382-10 | 63187-382 | Proficient Rx LP | 10 TABLET in 1 BOTTLE (63187-382-10) | February 1, 2019 |
| 63187-382-20 | 63187-382 | Proficient Rx LP | 20 TABLET in 1 BOTTLE (63187-382-20) | September 1, 2016 |
| 63187-382-30 | 63187-382 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-382-30) | September 1, 2016 |
| 63187-382-40 | 63187-382 | Proficient Rx LP | 40 TABLET in 1 BOTTLE (63187-382-40) | September 1, 2016 |
| 63187-382-60 | 63187-382 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (63187-382-60) | September 1, 2016 |
| 63187-382-90 | 63187-382 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (63187-382-90) | September 1, 2016 |
| 70518-3070-2 | 70518-3070 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-3070-2) / 1 TABLET in 1 POUCH (70518-3070-3) | July 20, 2026 |
| 70518-4666-0 | 70518-4666 | REMEDYREPACK INC. | 50 POUCH in 1 BOX (70518-4666-0) / 1 TABLET in 1 POUCH (70518-4666-1) | May 27, 2026 |
| 70518-4666-2 | 70518-4666 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-4666-2) / 1 TABLET in 1 POUCH (70518-4666-1) | August 31, 2026 |
| 0555-0779-02 | 0555-0779 | Teva Pharmaceuticals USA, Inc. | 100 TABLET in 1 BOTTLE (0555-0779-02) | December 4, 1996 |
| 0555-0779-04 | 0555-0779 | Teva Pharmaceuticals USA, Inc. | 500 TABLET in 1 BOTTLE (0555-0779-04) | December 4, 1996 |
| 0555-0872-02 | 0555-0872 | Teva Pharmaceuticals USA, Inc. | 100 TABLET in 1 BOTTLE (0555-0872-02) | December 4, 1996 |
| 0555-0872-04 | 0555-0872 | Teva Pharmaceuticals USA, Inc. | 500 TABLET in 1 BOTTLE (0555-0872-04) | December 4, 1996 |
| 0555-0873-02 | 0555-0873 | Teva Pharmaceuticals USA, Inc. | 100 TABLET in 1 BOTTLE (0555-0873-02) | December 4, 1996 |
| 0555-0873-04 | 0555-0873 | Teva Pharmaceuticals USA, Inc. | 500 TABLET in 1 BOTTLE (0555-0873-04) | December 4, 1996 |
| 50090-0166 | 50090-0166 | A-S Medication Solutions | — | December 4, 1996 |
| 50090-0490 | 50090-0490 | A-S Medication Solutions | — | December 4, 1996 |
| 50090-0491 | 50090-0491 | A-S Medication Solutions | — | December 3, 1996 |
| 60687-105 | 60687-105 | American Health Packaging | — | April 5, 2016 |
| 63629-2612 | 63629-2612 | Bryant Ranch Prepack | — | December 4, 1996 |
| 63629-8824 | 63629-8824 | Bryant Ranch Prepack | — | December 4, 1996 |
| 63629-8825 | 63629-8825 | Bryant Ranch Prepack | — | December 4, 1996 |
| 63629-8826 | 63629-8826 | Bryant Ranch Prepack | — | December 3, 1996 |
| 67046-1480 | 67046-1480 | Coupler LLC | — | January 30, 2025 |
| 59762-0055 | 59762-0055 | Mylan Pharmaceuticals Inc. | — | August 19, 2018 |
| 59762-0056 | 59762-0056 | Mylan Pharmaceuticals Inc. | — | June 3, 1959 |
| 59762-0058 | 59762-0058 | Mylan Pharmaceuticals Inc. | — | August 20, 2018 |
| 51655-520 | 51655-520 | Northwind Health Company, LLC | — | December 27, 2023 |
| 68071-4132 | 68071-4132 | NuCare Pharmaceuticals,Inc. | — | December 4, 1996 |
| 55289-160 | 55289-160 | PD-Rx Pharmaceuticals, Inc. | — | December 4, 1996 |
| 72789-043 | 72789-043 | PD-Rx Pharmaceuticals, Inc. | — | December 4, 1996 |
| 68788-8112 | 68788-8112 | Preferred Pharmaceuticals Inc. | — | December 6, 2021 |
| 68788-9899 | 68788-9899 | Preferred Pharmaceuticals, Inc. | — | February 13, 2012 |
| 63187-382 | 63187-382 | Proficient Rx LP | — | December 4, 1996 |
| 70518-3070 | 70518-3070 | REMEDYREPACK INC. | — | April 10, 2021 |
| 70518-4666 | 70518-4666 | REMEDYREPACK INC. | — | May 27, 2026 |
| 0555-0779 | 0555-0779 | Teva Pharmaceuticals USA, Inc. | — | December 4, 1996 |
| 0555-0872 | 0555-0872 | Teva Pharmaceuticals USA, Inc. | — | December 4, 1996 |
| 0555-0873 | 0555-0873 | Teva Pharmaceuticals USA, Inc. | — | December 3, 1996 |
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 |
Generated September 25, 2026 · 12 sections on this page.