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Medroxyprogesterone Acetate 10 mg Tablet, 100-count — NDC 70518-3070-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Medroxyprogesterone Acetate 10 mg Tablet, 100-count — NDC 70518-3070-2 (Billing 70518-3070-02)

by REMEDYREPACK INC. · 100 POUCH in 1 BOX / 1 TABLET in 1 POUCH

This is a package of 100 tablets of Medroxyprogesterone Acetate 10 mg Tablet from REMEDYREPACK INC., marketed since Apr 2021 and currently FDA-listed.

NDC 70518-3070-02
🏷️ FDA NDC (as labeled) 70518-3070-2 billing pads the package segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Product page 70518-3070-01 Also comes in: 30 tablets 70518-3070-1
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 6, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 70518-3070-2 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70518 labeler · 3070 product · 2 package
Package marketed since
Jul 20, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7051830702 2
FDA record last changed
Aug 6, 2026
⚠️
Other active recalls for Medroxyprogesterone Acetate (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 18, 2024 — CGMP Deviations (Eugia US LLC) · FDA recall D-0185-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70518-3070-2
Product NDC 70518-3070
11-digit billing NDC 70518307002
RxCUI 1000114
UNII C2QI4IOI2G
Application # ANDA040159
SPL Set ID e3dfd683-d44e-427b-af06-70b9b698e016
Established class (EPC) Progestin
Chemical class Progesterone Congeners
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-04-10
Route ORAL
Dosage form TABLET
Substance MEDROXYPROGESTERONE ACETATE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 1000114
Why two NDCs? The FDA registers this code as 70518-3070-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70518-3070-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Progestin class.

Pharmacologic class Progestin
Drug family (ATC) Progestogens, Pregnen (4) derivatives, Progestogens
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It depends on the form. The injections prevent pregnancy, and Depo-SubQ Provera 104 also manages endometriosis-associated pain. The tablets treat missed periods and abnormal uterin...
  • Depo-Provera CI and other medroxyprogesterone injectable suspensions are given into a muscle about every 3 months (13 weeks). Depo-SubQ Provera 104 is given under the skin about ev...
  • Changes in your bleeding pattern are the most common, and periods often stop over time. Headache, weight gain, injection site reactions and mood changes can also occur. Call your d...
  • Yes, it can lower bone mineral density, and the loss may not fully come back after stopping. That is why it is not recommended for more than 2 years unless other options are inadeq...
📖 Read our full Medroxyprogesterone guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70518-3070-01 70518-3070-1 Main listing 30 TABLET in 1 BLISTER PACK 2021-11-11 — Discontinued by firm
70518-3070-02 You're viewing this 100 POUCH in 1 BOX / 1 TABLET in 1 POUCH 2026-07-20 — Active

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 pouch in 1 box / 1 tablet in 1 pouch.
How does this package differ from NDC 70518-3070-01?
Both are Medroxyprogesterone Acetate 10 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 70518-3070-01 is the 30 tablets package.
What NDC number is used to bill for this package of Medroxyprogesterone Acetate 10 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Medroxyprogesterone Acetate 10 mg 60687-0105-21 American 30 tablets $0.152 AB Availability likely —
Medroxyprogesterone Acetate 10 mg 00555-0779-02 Teva 100 tablets $0.152 AB Availability likely —
medroxyprogesterone acetate 10 mg 59762-0056-01 Mylan 100 tablets $0.152 AB Availability likely —
Medroxyprogesterone Acetate 10 mg 63187-0382-10 Proficient 10 tablets — AB FDA listed —
Provera 10 mg 00009-0051-01 Pharmacia 100 tablets — AB FDA listed —
Medroxyprogesterone Acetate 10 mg 63629-8824-01 Bryant 100 tablets — AB FDA listed —
Medroxyprogesterone Acetate 10 mg 55289-0160-05 PD-Rx 5 tablets — AB FDA listed —
Medroxyprogesterone Acetate 10 mg 68071-4132-01 NuCare 10 tablets — AB FDA listed —
Medroxyprogesterone Acetate 10 mg 68788-9899-01 Preferred 10 tablets — AB FDA listed —
Medroxyprogesterone Acetate 10 mg 50090-0166-00 A-S 10 tablets — AB FDA listed —
Medroxyprogesterone Acetate 10 mg 63629-2612-01 Bryant 10 tablets — AB FDA listed —
Medroxyprogesterone Acetate 10 mg 51655-0520-52 Northwind 30 tablets — AB FDA listed —
Medroxyprogesterone Acetate 10 mgthis 70518-3070-02 REMEDYREPACK 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Apr 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeRound
Imprint555;779;b
Size7 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII NPU9M2E6L8
    Methylcellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and a viscosity builder in liquid formulations.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerREMEDYREPACK INC.
Application holderBARR LABORATORIES INC
FDA applicationANDA040159 (ANDA)
Labeler code70518
First marketedApr 2021
Product typeHuman Prescription Drug
Portfolio1,527 products on file

More NDCs from REMEDYREPACK INC. labeler code 70518

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug / Laboratory Test Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: 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 tablets (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 61 words ▾

INDICATIONS 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 ~2 min read ▾

DOSAGE 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 WARNINGS ).

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 72 words ▾

CONTRAINDICATIONS Medroxyprogesterone acetate is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding. Known, suspected, or history of breast cancer. Known or suspected estrogen- or progesterone-dependent neoplasia.

Active DVT, PE, or a history of these conditions Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions. Known anaphylactic reaction or angioedema to medroxyprogesterone acetate. Known liver impairment or disease.

Known or suspected pregnancy.

⚠️ Warnings ~3 min read ▾

WARNINGS 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-… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

ADVERSE 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; arthalgias; leg cramps; changes in libido; urticaria, angioedema, anaphylactoid/anaplylactic reactions; hypocalcemia; exacerbation of asthma; increased triglycerides.

🔄 Drug / Laboratory Test Interactions 206 words ▾

C. Drug-Laboratory Test Interactions The following laboratory results may be altered by the use of estrogen plus progestin therapy: Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.

Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay, T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Women on thyroid replacement therapy may require higher doses of thyroid hormone.

Other binding proteins may be elevated in serum for example, corticosteroid binding globulin (CBG), sex hormone binding globulin (SHBG) leading to increased circulating corticosteroid and sex steroids, respectively. Free hormone concentrations, such as testosterone and estradiol, may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).

Increased plasma high-density lipoprotein (HDL) and HDL2 cholesterol subfraction concentrations, reduced low-density lipoprotein (LDL) cholesterol concentration, increased triglycerides levels. Impaired glucose tolerance.

🤰 Pregnancy 57 words ▾

E. Pregnancy Medroxyprogesterone acetate should not be used during pregnancy (see CONTRAINDICATIONS . ) There may be increased risks for hypospadias, clitoral enlargement and labial fusion in children whose mothers are exposed to medroxyprogesterone acetate during the first trimester of pregnancy. However, a clear association between these conditions with use of medroxyprogesterone acetate has not been established.

🧒 Pediatric Use 21 words ▾

G. Pediatric Use Medroxyprogesterone acetate tablets are not indicated in children. Clinical studies have not been conducted in the pediatric population.

🧓 Geriatric Use 166 words ▾

H. Geriatric Use There have not been sufficient numbers of geriatric women involved in clinical studies utilizing medroxyprogesterone acetate alone to determine whether those over 65 years of age differ from younger subjects in their response to medroxyprogesterone acetate alone. The Women’s Health Initiative Studies In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age (see CLINICAL STUDIES ).

The Women’s Health Initiative Memory Study In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen- alone or estrogen plus progestin when compared to placebo (see WARNINGS , Probable Dementia ). Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women (see WARNINGS , Probable Dementia ).

🆘 Overdosage 57 words ▾

OVERDOSAGE 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.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Medroxyprogesterone acetate (MPA) administered orally or parenterally in the recommended doses to women with adequate endogenous estrogen, transforms proliferative into secretory endometrium. Androgenic and anabolic effects have been noted, but the drug is apparently devoid of significant estrogenic activity. While parenterally administered MPA inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation, available data indicate that this does not occur when the usually recommended oral dosage is given as single daily doses.

Pharmacokinetics The pharmacokinetics of MPA were determined in 20 postmenopausal women following a single-dose administration of eight medroxyprogesterone acetate 2.5 mg tablets or a single administration of two medroxyprogesterone acetate 10 mg tablets under fasting conditions. In another study, the steady-state pharmacokinetics of MPA were determined under fasting conditions in 30 postmenopausal women following daily administration of one medroxyprogesterone acetate 10 mg tablet for 7 days. In both studies, MPA was quantified in serum using a validated gas chromatography-mass spectrometry (GC-MS) method.

Estimates of the pharmacokinetic parameters of MPA after single and multiple doses of medroxyprogesterone acetate tablets were highly variable and are summarized in Table 1. Table 1. Mean (SD) Pharmacokinetic Parameters for Medroxyprogesterone Acetate (MPA) Tablet Strength C max (ng/mL) T max (h) Auc 0-(∞) (ng·h/mL) t 1/2 (h) Vd/f (L) CL/f (mL/min) Single Dose 2 x 10 mg 1.01 (0.599) 2.65 (1.41) 6.95 (3.39) 12.1 (3.49) 78024 (47220) 64110 (42662) 8 x 2.5 mg 0.805 (0.413) 2.22 (1.39) 5.62 (2.79) 11.6 (2.81) 62748 (40146) 74123 (35126) Multiple Dose 10 mg * 0.71 (0.35) 2.83 (1.83) 6.01 (3.16) 16.6 (15) 40564 (38256) 41963 (38402) *Following Day 7 dose A.

Absorption No specific investigation on the absolute bioavailability of MPA in humans has been conducted. MPA is rapidly absorbed from the gastrointestinal tract, and maximum MPA concentrations are obtained between 2 to 4 hours after oral administration. Administration of medroxyprogesterone acetate tablets with food increases the bioavailability of MPA.

A 10 mg dose of medroxyprogesterone acetate tablets, taken immediately before or after a meal, increased MPA C max (50 to 70%) and AUC (18 to 33%). The half-life of MPA was not changed with food. B.

Distribution MPA is approximately 90% protein bound, primarily to albumin; no MPA binding occurs with sex hormone binding globulin. C. Metabolism Following oral dosing, MPA is extensively metabolized in the liver via hydroxylation, with subsequent conjugation and elimination in the urine.

D. Excretion Most MPA metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates. E.

Specific Populations Hepatic Insufficiency MPA is almost exclusively eliminated via hepatic metabolism. In 14 patients with advanced liver disease, MPA disposition was significantly altered (reduced elimination). In patients with fatty liver, the mean percent dose excreted in the 24-hour urine as intact MPA after a 10 mg or 100 mg dose was 7.3% and 6.4%, respectively.

Renal Insufficiency The effect of renal impairment on the pharmacokinetics of medroxyprogesterone acetate has not been studied. F. Drug Interactions Medroxyprogesterone acetate (MPA) is metabolized in-vitro primarily by hydroxylation via the CYP3A4.

Specific drug-drug interaction studies evaluating the clinical effects with CYP3A4 inducers or inhibitors on MPA have not been conducted. Inducers and/or inhibitors of CYP3A4 may affect the metabolism of MPA.

📦 How Supplied / Storage and Handling 119 words ▾

HOW SUPPLIED Medroxyprogesterone acetate tablets, USP are available as: 10 mg: White, round, scored, biconvex tablet. Debossed with 555/779 on the scored side and stylized b on the other side, available in NDC: 70518-3070-00 NDC: 70518-3070-01 NDC: 70518-3070-02 NDC: 70518-3070-03 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK OUTER PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr.

Suite #4 Indiana, PA 1-724-465-8762

📋 Description 119 words ▾

DESCRIPTION Medroxyprogesterone acetate tablets, USP contain medroxyprogesterone acetate, USP 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: C 24 H 34 O 4 M.W. 386.53 Each tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate, USP and the following inactive ingredients: crospovidone, lactose monohydrate, magnesium stearate, methylcellulose, pregelatinized corn starch, and sodium lauryl sulfate. structure formula

⚠️ Precautions ~3 min read ▾

PRECAUTIONS A. General Addition of a progestin when a woman has not had a hysterectomy Studies of the addition of a progestin for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer.

There are, however, possible risks that may be associated with the use of progestins with estrogens compared to estrogen-alone regimens. These include an increased risk of breast cancer. Unexpected abnormal vaginal bleeding In cases of unexpected abnormal vaginal bleeding, adequate diagnostic measures are indicated.

Elevated blood pressure Blood pressure should be monitored at regular intervals with estrogen plus progestin therapy. Hypertriglyceridemia In women with pre-existing hypertriglyceridemia, estrogen plus progestin therapy may be associated with elevations of plasma triglycerides leading to pancreatitis. Consider discontinuation of treatment if pancreatitis occurs.

Hepatic Impairment and/or past history of cholestatic jaundice Estrogens plus progestins may be poorly metabolized in women with impaired liver function. For women with a history of cholestatic jaundice associated with past estrogen use or with pregnancy, caution should be exercised, and in the case of recurrence, medication should be discontinued. Fluid Retention Progestins may cause some degree of fluid retention.

Women who have conditions which might be influenced by this factor, such as cardiac or renal impairment, warrant careful observation when estrogen plus progestin are prescribed. Hypocalcemia Estrogen plus progestin therapy should be used with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur. Exacerbation of other conditions Estrogen plus progestin therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas and should be used with caution in women with these conditions.

B. Patient Information Physicians are advised to discuss the Patient Information leaflet with women for whom they prescribe medroxyprogesterone acetate. There may be an increased risk of minor birth defects in children whose mothers are exposed to progestins during the first trimester of pregnancy.

The possible risk to the male baby is hypospadias, a condition in which the opening of the penis is on the underside rather than the tip of the penis. This condition occurs naturally in approximately 5 to 8 per 1000 male births. The risk may be increased with exposure to medroxyprogesterone acetate.

Enlargement of the clitoris and fusion of the labia may occur in female babies. However, a clear association between hypospadias, clitoral enlargement and labial fusion with use of medroxyprogesterone acetate has not been established. Inform the patient of the importance of reporting exposure to medroxyprogesterone acetate in early pregnancy.

C. Drug-Laboratory Test Interactions The following laboratory results may be altered by the use of estrogen plus progestin therapy: Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of anti-factor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.

Increased thyroid-binding globulin (TBG) levels leading to increased circulating total thyroid hormone levels as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay, T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Women on thyro… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 27 words ▾

F. Nursing Mothers Medroxyprogesterone acetate should not be used during lactation. Detectable amounts of progestin have been identified in the breast milk of nursing mothers receiving progestins.

🧬 Pharmacokinetics ~2 min read ▾

Pharmacokinetics The pharmacokinetics of MPA were determined in 20 postmenopausal women following a single-dose administration of eight medroxyprogesterone acetate 2.5 mg tablets or a single administration of two medroxyprogesterone acetate 10 mg tablets under fasting conditions. In another study, the steady-state pharmacokinetics of MPA were determined under fasting conditions in 30 postmenopausal women following daily administration of one medroxyprogesterone acetate 10 mg tablet for 7 days. In both studies, MPA was quantified in serum using a validated gas chromatography-mass spectrometry (GC-MS) method.

Estimates of the pharmacokinetic parameters of MPA after single and multiple doses of medroxyprogesterone acetate tablets were highly variable and are summarized in Table 1. Table 1. Mean (SD) Pharmacokinetic Parameters for Medroxyprogesterone Acetate (MPA) Tablet Strength C max (ng/mL) T max (h) Auc 0-(∞) (ng·h/mL) t 1/2 (h) Vd/f (L) CL/f (mL/min) Single Dose 2 x 10 mg 1.01 (0.599) 2.65 (1.41) 6.95 (3.39) 12.1 (3.49) 78024 (47220) 64110 (42662) 8 x 2.5 mg 0.805 (0.413) 2.22 (1.39) 5.62 (2.79) 11.6 (2.81) 62748 (40146) 74123 (35126) Multiple Dose 10 mg * 0.71 (0.35) 2.83 (1.83) 6.01 (3.16) 16.6 (15) 40564 (38256) 41963 (38402) *Following Day 7 dose A.

Absorption No specific investigation on the absolute bioavailability of MPA in humans has been conducted. MPA is rapidly absorbed from the gastrointestinal tract, and maximum MPA concentrations are obtained between 2 to 4 hours after oral administration. Administration of medroxyprogesterone acetate tablets with food increases the bioavailability of MPA.

A 10 mg dose of medroxyprogesterone acetate tablets, taken immediately before or after a meal, increased MPA C max (50 to 70%) and AUC (18 to 33%). The half-life of MPA was not changed with food. B.

Distribution MPA is approximately 90% protein bound, primarily to albumin; no MPA binding occurs with sex hormone binding globulin. C. Metabolism Following oral dosing, MPA is extensively metabolized in the liver via hydroxylation, with subsequent conjugation and elimination in the urine.

D. Excretion Most MPA metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates. E.

Specific Populations Hepatic Insufficiency MPA is almost exclusively eliminated via hepatic metabolism. In 14 patients with advanced liver disease, MPA disposition was significantly altered (reduced elimination). In patients with fatty liver, the mean percent dose excreted in the 24-hour urine as intact MPA after a 10 mg or 100 mg dose was 7.3% and 6.4%, respectively.

Renal Insufficiency The effect of renal impairment on the pharmacokinetics of medroxyprogesterone acetate has not been studied. F. Drug Interactions Medroxyprogesterone acetate (MPA) is metabolized in-vitro primarily by hydroxylation via the CYP3A4.

Specific drug-drug interaction studies evaluating the clinical effects with CYP3A4 inducers or inhibitors on MPA have not been conducted. Inducers and/or inhibitors of CYP3A4 may affect the metabolism of MPA.

🔬 Clinical Studies ~3 min read ▾

CLINICAL STUDIES Effects on the Endometrium In a 3-year, double-blind, placebo-controlled study of 356 nonhysterectomized, postmenopausal women between 45 and 64 years of age randomized to receive placebo (n=119), 0.625 mg conjugated estrogen only (n=119), or 0.625 mg conjugated estrogen plus cyclic medroxyprogesterone acetate (n=118), results showed a reduced risk of endometrial hyperplasia in the treatment group receiving 10 mg medroxyprogesterone acetate plus 0.625 mg conjugated estrogens compared to the group receiving 0.625 mg conjugated estrogens only.

See Table 2. Table 2. Number (%) of Endometrial Biopsy Changes Since Baseline After 3 Years of Treatment* Histological Results Placebo (n=119) CEE a (n=119) Medroxyprogesterone Acetate b + CEE (n=118) Normal/No hyperplasia (%) 116 (97) 45 (38) 112 (95) Simple (cystic) hyperplasia (%) 1 (1) 33 (28) 4 (3) Complex (adenomatous) hyperplasia (%) 1 (1) 27 (22) 2 (2) Atypia (%) 0 14 (12) 0 Adenocarcinoma (%) 1 (1) 0 0 * Includes most extreme abnormal result a.

CEE = conjugated equine estrogens 0.625 mg/day b. Medroxyprogesterone acetate = medroxyprogesterone acetate tablets 10 mg/day for 12 days In a second 1-year study, 832 postmenopausal women between 45 and 65 years of age were treated with daily 0.625 mg conjugated estrogen (days 1 to 28), plus either 5 mg cyclic medroxyprogesterone acetate or 10 mg cyclic medroxyprogesterone acetate (days 15 to 28), or daily 0.625 mg conjugated estrogen only. The treatment groups receiving 5 or 10 mg cyclic medroxyprogesterone acetate (days 15 to 28) plus daily conjugated estrogens showed a significantly lower rate of hyperplasia as compared to the conjugated estrogens only group.

See Table 3. Table 3. Number (%) of Women with Endometrial Hyperplasia at 1 Year CEE a MPA b + CEE a (n=283) MPA 5 mg (n=277) MPA 10 mg (n=272) Cystic hyperplasia (%) 55 (19) 3 (1) 0 Adenomatous hyperplasia without atypia 2 (1) 0 0 a.

CEE = conjugated equine estrogen 0.625 mg every day of a 28-day cycle. b. Cyclic medroxyprogesterone acetate on days 15 to 28 Women’s Health Initiative Studies The WHI enrolled approximately 27,000 predominantly healthy postmenopausal women in two substudies to assess the risks and benefits of daily oral CE (0.625 mg)-alone or in combination with MPA (2.5 mg) compared to placebo in the prevention of certain chronic diseases. The primary endpoint was the incidence of coronary heart disease (CHD) (defined as nonfatal MI, silent MI and CHD death), with invasive breast cancer as the primary adverse outcome.

A “global index” included the earliest occurrence of CHD, invasive breast cancer, stroke, PE, endometrial cancer (only in the CE plus MPA substudy), colorectal cancer, hip fracture, or death due to other cause. These substudies did not evaluate the effects of CE-alone or CE plus MPA on menopausal symptoms. WHI Estrogen Plus Progestin Substudy The WHI estrogen plus progestin substudy was stopped early.

According to the predefined stopping rule, after an average follow-up of 5.6 years of treatment, the increased risk of invasive breast cancer and cardiovascular events exceeded the specified benefits included in the “global index.” The absolute excess risk of events included in the “global index” was 19 per 10,000 women-years. For those outcomes included in the WHI “global index” that reached statistical significance after 5.6 years of follow-up, the absolute excess risks per 10,000 women-years in the group treated with CE plus MPA were 7 more CHD events, 8 more strokes, 10 more PEs, and 8 more invasive breast cancers, while the absolute risk reduction per 10,000 women-years were 6 fewer colorectal cancers and 5 fewer hip fractures.

Results of the CE plus MPA substudy, which included 16,608 women (average 63 years of age, range 50 to 79; 83.9 percent White, 6.8 percent Black, 5.4 percent Hispanic, 3.9 percent Other) are presented in Table 4. These results reflect centrally adjudicated data after an average follow-up of 5.6 years. Table 4:… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 109 words ▾

D. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity: Long-term intramuscular administration of medroxyprogesterone acetate has been shown to produce mammary tumors in beagle dogs. There was no evidence of a carcinogenic effect associated with the oral administration of medroxyprogesterone acetate to rats and mice.

Long-term continuous administration of estrogen plus progestin therapy has shown an increased risk of breast cancer and ovarian cancer (see WARNINGS and PRECAUTIONS ). Genotoxicity: Medroxyprogesterone acetate was not mutagenic in a battery of in vitro or in vivo genetic toxicity assays. Fertility: Medroxyprogesterone acetate at high doses is an antifertility drug and high doses would be expected to impair fertility until the cessation of treatment.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION MedroxyPROGESTERone Acetate (med rox″ ee proe jes′ ter one as′ etate) Tablets Read this Patient Information before you start taking medroxyprogesterone acetate tablets and read what you get each time you refill your medroxyprogesterone acetate tablets prescription. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about medroxyprogesterone acetate tablets (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. What are medroxyprogesterone acetate tablets?

Medroxyprogesterone acetate tablet is a medicine that contains medroxyprogesterone acetate, a progestin hormone. What are medroxyprogesterone acetate tablets used for? Medroxyprogesterone acetate tablets are used to: Treat menstrual periods that have stopped or to treat abnormal uterine bleeding.

Women with a uterus who are not pregnant, who stop having regular menstrual periods or who begin to have irregular menstrual periods may have a drop in their progesterone level. Talk with your healthcare provider about whether medroxyprogesterone acetate tablets are right for you. Reduce your chances of getting cancer of the uterus (womb).

In postmenopausal women with a uterus who use estrogens, taking progestin in combination with estrogen will reduce your chance of getting cancer of the uterus (womb). Who should not take medroxyprogesterone acetate tablets? Do not start taking medroxyprogesterone acetate tablets if you: have unusual vaginal bleeding currently have or have had certain cancers Estrogen plus progestin may increase your chance of getting certain types of cancers, including cancer of the breast.

If you have or have had cancer, talk with your healthcare provider about whether you should use medroxyprogesterone acetate tablets. had a stroke or heart attack currently have or have had blood clots currently have or have had liver problems are allergic to medroxyprogesterone acetate tablets or any of its ingredients See the list of ingredients in medroxyprogesterone acetate tablets at the end of this leaflet. think you may be pregnant Medroxyprogesterone acetate tablets are not for pregnant women. If you think you may be pregnant, you should have a pregnancy test and know the results.

Do not use medroxyprogesterone acetate tablets if the test is positive and talk to your healthcare provider. There may be an increased risk of minor birth defects in children whose mothers take medroxyprogesterone acetate tablets during the first 4 months of pregnancy. Medroxyprogesterone acetate tablets should not be used as a test for pregnancy.

What should I tell my healthcare provider before taking medroxyprogesterone acetate tablets? Before you take medroxyprogesterone acetate tablets, tell your healthcare provider if you: have any other medical problems Your healthcare provider may need to check you more carefully if you have certain conditions such as asthma (wheezing), epilepsy (seizures), diabetes, migraine, endometriosis (severe pelvic pain), lupus, or problems with your heart, liver, thyroid, kidneys, or have high calcium in your blood. are going to have surgery or will be on bed rest Your healthcare provider will let you know if you need to stop taking medroxyprogesterone acetate tablets. are breast feeding The hormone in medroxyprogesterone acetate can pass into your breast milk.

Tell your healthcare provider about all the medicines you tak… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 80 words ▾

DRUG: Medroxyprogesterone Acetate GENERIC: Medroxyprogesterone Acetate DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-3070-0 NDC: 70518-3070-1 NDC: 70518-3070-2 NDC: 70518-3070-3 COLOR: white SHAPE: ROUND SCORE: Two even pieces SIZE: 7 mm IMPRINT: 555;779;b PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 30 in 1 BLISTER PACK OUTER PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH ACTIVE INGREDIENT(S): MEDROXYPROGESTERONE ACETATE 10mg in 1 INACTIVE INGREDIENT(S): CROSPOVIDONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHYLCELLULOSE (15 CPS) STARCH, CORN SODIUM LAURYL SULFATE MM1 MM2 MM3 MM4

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Medroxyprogesterone Acetate — the program that covers self-administered drugs. 9 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Medroxyprogesterone Acetate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.74M
Claims incl. refills
89.6K
Beneficiaries
65K
Spend / beneficiary
$26.74
Spend / claim
$19.41
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
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“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by REMEDYREPACK INC.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (70518-3070-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
REMEDYREPACK INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70518-3066-00 · REMEDYREPACK 70518-3078-00 · REMEDYREPACK →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.