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medroxyprogesterone acetate 150 mg/mL Injection, Suspension, 1 vial — NDC 50090-5619-0 (Billing 50090-5619-00)

by A-S Medication Solutions · 1 VIAL in 1 CARTON / 1 mL in 1 VIAL

This is a package of 1 vial of medroxyprogesterone acetate 150 mg/mL Injection, Suspension from A-S Medication Solutions, marketed since Jul 2021 and currently FDA-listed. It is this product's only package size.

NDC 50090-5619-00
🏷️ FDA NDC (as labeled) 50090-5619-0 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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 50090-5619-0 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
50090 labeler · 5619 product · 0 package
Package marketed since
Aug 25, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5009056190 6
FDA record last changed
Jul 24, 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) 50090-5619-0
Product NDC 50090-5619
11-digit billing NDC 50090561900
NCPDP billing unit ML — per mL (volume)
RxCUI 1000126
UNII C2QI4IOI2G
Application # NDA020246
SPL Set ID 5e817926-ba15-4d16-9463-88f6ff3bd3ac
Established class (EPC) Progestin
Chemical class Progesterone Congeners
DEA schedule Non-controlled
Marketing category NDA AUTHORIZED GENERIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-07-06
Route INTRAMUSCULAR
Dosage form INJECTION, SUSPENSION
Substance MEDROXYPROGESTERONE ACETATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 017584
GCN 11251
HICL code 001442
Ingredient (HICL) Medroxyprogesterone Acetate
HIC1 code G
Therapeutic class — broad (HIC1) Female Genital System
HIC2 code G8
Therapeutic class — intermediate (HIC2) Systemic Antifertility Agents
HIC3 code G8C
Therapeutic class — specific (HIC3) Contraceptives,Injectable
AHFS code 68:32.00.00
AHFS class Progestins
FDB label name MEDROXYPROGESTERONE 150 MG/ML
FDB brand name Medroxyprogesterone Acetate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 017584
  • GCN: 11251
  • HICL (First Databank): 001442
  • AHFS class code: 68:32.00.00
  • RxCUI (RxNorm): 1000126
Why two NDCs? The FDA registers this code as 50090-5619-0 — 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 → 50090-5619-00. 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

Label name MEDROXYPROGESTERONE 150 MG/ML Ingredient Medroxyprogesterone Acetate
📗 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 mLPer 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 · Q2 2026 $27.44 $27.44 / 1 ml
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
50090-5619-00 You're viewing this Main listing 1 VIAL in 1 CARTON / 1 mL in 1 VIAL 2021-08-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Medroxyprogesterone Acetate 150 mg/mL 00548-5400-00 Amphastar 1 vial $18.854 AB Availability likely —
Medroxyprogesterone Acetate 150 mg/mL 55150-0329-01 Eugia 1 vial $18.854 AB Availability likely —
Medroxyprogesterone Acetate 150 mg/mL 60219-1467-01 Amneal 1 vial $18.854 AB Availability likely —
medroxyprogesterone acetate 150 mg/mL 70121-1467-02 Amneal 1 vial $18.854 AB Availability likely —
Medroxyprogesterone Acetate 150 mg/mL 70700-0315-22 Xiromed 1 ml $18.854 AB Availability likely —
medroxyprogesterone acetate 150 mg/mL 66993-0370-25 Prasco 25 vials $22.850 AB Availability likely —
Medroxyprogesterone Acetate 150 mg/mL 67457-0887-01 Mylan 25 vials $22.850 AB Availability likely —
Medroxyprogesterone Acetate 150 mg/mL 00548-5410-00 Amphastar 1 vial $26.215 AB Discontinued —
Medroxyprogesterone Acetate 150 mg/mL 62756-0090-40 Sun 1 vial $26.215 — FDA listed —
Medroxyprogesterone Acetate 150 mg/mL 00548-5701-00 Amphastar 1 syringe $27.364 AB Availability likely —
medroxyprogesterone acetate 150 mg/mL 66993-0371-79 Prasco 1 syringe $27.364 AB Availability likely —
medroxyprogesterone acetate 150 mg/mL 70121-1480-01 Amneal 1 syringe $27.364 AB Availability likely —
Medroxyprogesterone Acetate 150 mg/mL 55150-0330-01 Eugia 1 syringe $27.364 AB Availability likely —
Medroxyprogesterone Acetate 150 mg/mL 00548-5711-00 Amphastar 1 syringe $38.621 AB Discontinued —
Medroxyprogesterone Acetate 150 mg/mL 62756-0091-40 Sun 1 syringe $38.621 — FDA listed —
Depo-Provera 150 mg/mL 00009-0746-30 Pharmacia 1 vial $50.994 AB Availability likely —
Depo-Provera 150 mg/mL 00009-7376-11 Pharmacia 1 syringe $52.335 AB Availability likely —
Medroxyprogesterone Acetate Injectable Suspension 150 mg/mL 24201-0150-01 Hikma 1 vial — — FDA listed —
medroxyprogesterone acetate 150 mg/mLthis 50090-5619-00 A-S 1 vial — AB FDA listed —
medroxyprogesterone acetate 150 mg/mL 50090-5925-00 A-S 1 syringe — AB FDA listed —
medroxyprogesterone acetate 150 mg/mL 70518-4324-00 REMEDYREPACK 1 syringe — AB FDA listed —
About this product: this is an authorized generic — the brand-name product marketed without its brand name. 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
Jul 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerA-S Medication Solutions
Application holderPFIZER INC
FDA applicationNDA020246 (NDA AUTHORIZED GENERIC)
Labeler code50090
First marketedJul 2021
Product typeHuman Prescription Drug
Portfolio2,811 products on file

More NDCs from A-S Medication Solutions labeler code 50090

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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~1 min read ▾

WARNING: LOSS OF BONE MINERAL DENSITY • Women who use Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible [see Warnings and Precautions (5.1) ] . • It is unknown if use of MPA Injectable Suspension, USP during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life [see Warnings and Precautions (5.1) ] . • MPA Injectable Suspension, USP is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Indications and Usage (1) and Warnings and Precautions (5.1) ] .

WARNING: LOSS OF BONE MINERAL DENSITY See full prescribing information for complete boxed warning . • Women who use Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. ( 5.1 ) • It is unknown if use of MPA Injectable Suspension, USP during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.

( 5.1 ) • MPA Injectable Suspension, USP is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. ( 1 , 5.1 )

🎯 Indications and Usage 122 words ▾

1 INDICATIONS AND USAGE Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP is indicated for use by females of reproductive potential to prevent pregnancy. Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP is a progestin indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Use: The use of MPA Injectable Suspension, USP is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate.

( 1 , 5.1 ) Limitations of Use : The use of MPA Injectable Suspension, USP is not recommended as a long‑term (i.e., longer than 2 years) birth control method unless other options are considered inadequate [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ].

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dose is 150 mg of MPA Injectable Suspension, USP every 3 months (13 weeks) administered by deep, intramuscular (IM) injection in the gluteal or deltoid muscle. ( 2.1 )

2.1Prevention of Pregnancy Both the 1 mL vial and the 1 mL prefilled syringe of MPA Injectable Suspension, USP should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension. The recommended dose is 150 mg of MPA Injectable Suspension, USP every 3 months (13 weeks) administered by deep intramuscular (IM) injection using strict aseptic technique in the gluteal or deltoid muscle, rotating the sites with every injection. As with any IM injection, to avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to each injection to determine if a longer needle is necessary particularly for gluteal IM injection.

Use for longer than 2 years is not recommended (unless other birth control methods are considered inadequate) due to the impact of long-term MPA Injectable Suspension, USP treatment on bone mineral density (BMD) [see Warnings and Precautions (5.1) ] . Dosage does not need to be adjusted for body weight [see Clinical Studies (14.1) ] . To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period or within the first 5-days post‑partum.

In post-partum mothers who exclusively breastfeed, administer MPA Injectable Suspension, USP during or after the sixth post‑partum week. If the time interval between injections is greater than 13 weeks, the physician should determine that the patient is not pregnant before administering the drug. The efficacy of MPA Injectable Suspension, USP depends on adherence to the dosage schedule of administration.

2.2Switching from Other Methods of Contraception When switching from other contraceptive methods, MPA Injectable Suspension, USP should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, (e.g., patients switching from oral contraceptives should have their first injection of MPA Injectable Suspension, USP on the day after the last active tablet or at the latest, on the day following the final inactive tablet).

💊 Dosage Forms and Strengths 57 words ▾

3 DOSAGE FORMS AND STRENGTHS Sterile Aqueous suspension: 150 mg/mL Prefilled syringes are available packaged with 22-gauge × 1 1/2 inch Terumo® SurGuard™ Needles. • Vials containing sterile aqueous suspension: 150 mg per mL. ( 3 ) • Prefilled syringes: prefilled syringes are available packaged with 22‑gauge × 1 1/2 inch Terumo® SurGuard™ Needles. ( 3 )

⛔ Contraindications 156 words ▾

4 CONTRAINDICATIONS The use of MPA Injectable Suspension, USP is contraindicated in the following conditions: • Active thrombophlebitis, or current or history of thromboembolic disorders, or cerebral vascular disease [see Warnings and Precautions (5.2) ] . • Known or suspected malignancy of breast [see Warnings and Precautions (5.3) ] . • Known hypersensitivity to MPA Injectable Suspension, USP (medroxyprogesterone acetate or any of its other ingredients) [see Warnings and Precautions (5.6) ] . • Significant liver disease [see Warnings and Precautions (5.8) ] . • Undiagnosed vaginal bleeding [see Warnings and Precautions (5.11) ] . • Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease.

( 4 ) • Known or suspected malignancy of breast. ( 4 ) • Known hypersensitivity to MPA Injectable Suspension, USP (medroxyprogesterone acetate or any of its other ingredients). ( 4 ) • Significant liver disease.

( 4 ) • Undiagnosed vaginal bleeding. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Thromboembolic Disorders: Discontinue MPA Injectable Suspension, USP in patients who develop thrombosis. ( 5.2 ) • Cancer Risks: Monitor women with a strong family history of breast cancer carefully. ( 5.3 ) • Meningioma: Discontinue MPA Injectable Suspension, USP if meningioma is diagnosed.

Monitor patients for signs and symptoms of meningioma. ( 5.4 ) • Ectopic Pregnancy: Consider ectopic pregnancy if a woman using MPA Injectable Suspension, USP becomes pregnant or complains of severe abdominal pain. ( 5.5 ) • Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment.

( 5.6 ) • Liver Function: Discontinue MPA Injectable Suspension, USP if jaundice or disturbances of liver function develop. ( 5.8 ) • Carbohydrate Metabolism: Monitor diabetic patients carefully. ( 5.13 )

5.1Loss of Bone Mineral Density Use of MPA Injectable Suspension, USP reduces serum estrogen levels and is associated with significant loss of bone mineral density (BMD). This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if use of MPA Injectable Suspension, USP by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.

A study to assess the reversibility of loss of BMD in adolescents was conducted with MPA Injectable Suspension, USP. After discontinuing MPA Injectable Suspension, USP in these adolescents, mean BMD loss at the total hip and femoral neck did not fully recover by 5 years (60 months) post-treatment in the sub-group of adolescents who were treated for more than 2 years [see Clinical Studies (14.3) ]. Similarly, in adults, there was only partial recovery of mean BMD at the total hip, femoral neck, and lumbar spine towards baseline by 2 years post-treatment [see Clinical Studies (14.2) ].

The use of MPA Injectable Suspension, USP is not recommended as a long-term (i.e., longer than 2 years) birth control method unless other options are considered inadequate. BMD should be evaluated when a woman needs to continue to use MPA Injectable Suspension, USP long-term. In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity.

Other birth control methods should be considered in the risk/benefit analysis for the use of MPA Injectable Suspension, USP in women with osteoporosis risk factors. MPA Injectable Suspension, USP can pose an additional risk in patients with risk factors for osteoporosis (e.g., metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids).

5.2Thromboembolic Disorders There have been reports of serious thrombotic events in women using MPA Injectable Suspension, USP (150 mg). However, MPA Injectable Suspension, USP has not been causally associated with the induction of thrombotic or thromboembolic disorders. Any patient who develops thrombosis while undergoing therapy with MPA Injectable Suspension, USP should discontinue treatment unless she has no other acceptable options for birth control.

Do not re-administer MPA Injectable Suspension, USP pending examination if there is a sudden partial or complete loss of vision or if there is a sudden onset of proptosis, diplopia, or migraine. Do not re-administer if examination reveals papilledema or retinal vascular lesions.

5.3Cancer Risks Breast Cancer Women who have or have had a history of breast cancer should not use hormonal contraceptives, including MPA Injectable Suspension, USP, because breast cancer may be hormonally sensitive [see Contraindications (4) ]. Women with a strong family history of breast cancer should be monitored with particular care. The results of five large case-control studies assessing the association between depo-medroxyprogesterone acetate (DMPA) use and the risk of breast cancer are summarized in… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions observed with the use of MPA Injectable Suspension, USP are discussed in greater detail in the Warnings and Precautions section (5) : • Loss of Bone Mineral Density [see Warnings and Precautions (5.1) ] • Thromboembolic disease [see Warnings and Precautions (5.2) ] • Breast Cancer [see Warnings and Precautions (5.3) ] • Anaphylaxis and Anaphylactoid Reactions [see Warnings and Precautions (5.6) ] • Bleeding Irregularities [see Warnings and Precautions (5.11) ] • Weight Gain [see Warnings and Precautions (5.12) ] Most common adverse reactions (incidence >5%): menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain >10 lb at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience Clinical trials are conducted under widely varying conditions, therefore, adverse reaction rates observed in the clinical studies 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. In the two clinical trials with MPA Injectable Suspension, USP, over 3,900 women, who were treated for up to 7 years, reported the following adverse reactions, which may or may not be related to the use of MPA Injectable Suspension, USP.

The population studied ranges in age from 15 to 51 years, of which 46% were White, 50% Non-White, and 4.9% Unknown race. The patients received 150 mg MPA Injectable Suspension, USP every 3-months (90 days). The median study duration was 13 months with a range of 1‑84 months.

Fifty‑eight percent of patients remained in the study after 13 months and 34% after 24 months. Table 1. Adverse Reactions that Were Reported by More than 5% of Subjects Body System Body System represented from COSTART medical dictionary.

Adverse Reactions [Incidence (%)] Body as a Whole Headache (16.5%) Abdominal pain/discomfort (11.2%) Metabolic/Nutritional Increased weight >10 lb at 24 months (37.7%) Nervous Nervousness (10.8%) Dizziness (5.6%) Libido decreased (5.5%) Reproductive (Urogenital 1 ) Menstrual irregularities: bleeding (57.3% at 12 months, 32.1% at 24 months) amenorrhea (55% at 12 months, 68% at 24 months) Table 2. Adverse Reactions that Were Reported by between 1 and 5% of Subjects Body System Body System represented from COSTART medical dictionary.

Adverse Reactions [Incidence (%)] Body as a Whole Asthenia/fatigue (4.2%) Backache (2.2%) Dysmenorrhea (1.7%) Hot flashes (1.0%) Digestive Nausea (3.3%) Bloating (2.3%) Metabolic/Nutritional Edema (2.2%) Musculoskeletal Leg cramps (3.7%) Arthralgia (1.0%) Nervous Depression (1.5%) Insomnia (1.0%) Skin and Appendages Acne (1.2%) No hair growth/alopecia (1.1%) Rash (1.1%) Reproductive (Urogenital 1 ) Leukorrhea (2.9%) Breast pain (2.8%) Vaginitis (1.2%) Adverse reactions leading to study discontinuation in ≥2% of subjects: bleeding (8.2%), amenorrhea (2.1%), weight gain (2.0%).

6.2Post-Marketing Experience The following adverse reactions have been identified during post approval use of MPA Injectable Suspension, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. There have been cases of osteoporosis including osteoporotic fractures reported post-marketing in patients taking MPA Injectable Suspension, USP.

Table 3. Adverse Reactions Reported during Post-Marketing Experience Body System Body System represented from COSTART medical dictionary. Adverse Reactions Body as a Whole Chest pain, Allergic reactions including angioedema, Fever, Injection site abscess Injection site abscess and injection site infections have been reported; therefore, strict ase… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of contraceptive drug products. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with MPA Injectable Suspension, USP. ( 7.1 )

7.1Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: • barbiturates • bosentan • carbamazepine • felbamate • griseofulvin • oxcarbazepine • phenytoin • rifampin • St.

John's wort • topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors : Significant changes (increase or decrease) in the plasma levels of progestin have been noted in some cases of co-administration of HIV protease inhibitors. Significant changes (increase or decrease) in the plasma levels of the progestin have been noted in some cases of co-administration with non-nucleoside reverse transcriptase inhibitors. Antibiotics : There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids.

Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

7.2Laboratory Test Interactions The pathologist should be advised of progestin therapy when relevant specimens are submitted. The following laboratory tests may be affected by progestins including MPA Injectable Suspension, USP: (a) Plasma and urinary steroid levels are decreased (e.g., progesterone, estradiol, pregnanediol, testosterone, cortisol). (b) Gonadotropin levels are decreased.

(c) Sex-hormone-binding-globulin concentrations are decreased. (d) Protein-bound iodine and butanol extractable protein-bound iodine may increase. T 3 -uptake values may decrease.

(e) Coagulation test values for prothrombin (Factor II), and Factors VII, VIII, IX, and X may increase. (f) Sulfobromophthalein and other liver function test values may be increased. (g) The effects of medroxyprogesterone acetate on lipid metabolism are inconsistent.

Both increases and decreases in total cholesterol, triglycerides, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol have been observed in studies.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Discontinue if pregnancy occurs. ( 8.1 ) • Lactation: Detectable amounts of drug have been identified in the milk of mothers receiving MPA Injectable Suspension, USP. ( 8.2 ) • Pediatric Patients: MPA Injectable Suspension, USP is not indicated before menarche. ( 8.4 )

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, MPA Injectable Suspension, USP should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to progestins before conception or during early pregnancy. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

8.2Lactation Risk Summary Although medroxyprogesterone acetate is detectable in the milk of mothers receiving MPA Injectable Suspension, USP, milk composition, quality, and amount do not appear to be adversely affected. Effects on milk production and lactation initiation/duration remain unclear when administered before 6 weeks after delivery, therefore, in mothers who exclusively breastfeed, initiate MPA Injectable Suspension, USP during or after the sixth post-partum week [see Dosage and Administration (2.1) ]. No adverse effects in breastfed infants would be expected with maternal use of progestins.

Neonates and infants exposed to medroxyprogesterone acetate from breast milk have been studied and no adverse effects have been noted. The developmental and health benefits of breast-feeding should be considered along with the mother’s clinical need for MPA Injectable Suspension, USP and any potential adverse effects on the breastfed child from MPA Injectable Suspension, USP or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential MPA Injectable Suspension, USP is indicated for the prevention of pregnancy and would therefore be expected to impair female fertility until cessation of treatment. Women may experience a delay in return to ovulation and fertility (conception) following discontinuation of MPA Injectable Suspension, USP [see Warnings and Precautions (5.15) ] .

8.4Pediatric Use MPA Injectable Suspension, USP is not indicated before menarche. Use of MPA Injectable Suspension, USP is associated with significant loss of BMD. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion.

In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. It is unknown if use of MPA Injectable Suspension, USP by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women.

8.5Geriatric Use This product has not been studied in post-menopausal women and is not indicated in this population.

🤰 Pregnancy 92 words ▾

8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, MPA Injectable Suspension, USP should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to progestins before conception or during early pregnancy. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

🧒 Pediatric Use 110 words ▾

8.4Pediatric Use MPA Injectable Suspension, USP is not indicated before menarche. Use of MPA Injectable Suspension, USP is associated with significant loss of BMD. This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion.

In adolescents, interpretation of BMD results should take into account patient age and skeletal maturity. It is unknown if use of MPA Injectable Suspension, USP by younger women will reduce peak bone mass and increase the risk of osteoporotic fractures in later life. Other than concerns about loss of BMD, the safety and effectiveness are expected to be the same for postmenarchal adolescents and adult women.

🧓 Geriatric Use 19 words ▾

8.5Geriatric Use This product has not been studied in post-menopausal women and is not indicated in this population.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action MPA Injectable Suspension, USP inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical mucus. These actions contribute to its contraceptive effect.

12.2Pharmacodynamics No specific pharmacodynamic studies were conducted with MPA Injectable Suspension, USP.

12.3Pharmacokinetics Absorption Following a single 150 mg IM dose of MPA Injectable Suspension, USP in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL. Distribution Plasma protein binding of medroxyprogesterone acetate averages 86%. Medroxyprogesterone acetate binding occurs primarily to serum albumin.

No binding of medroxyprogesterone acetate occurs with sex-hormone-binding globulin (SHBG). Elimination Metabolism Medroxyprogesterone acetate is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of MPA Injectable Suspension, USP is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

Specific Populations The effect of hepatic and/or renal impairment on the pharmacokinetics of MPA Injectable Suspension, USP is unknown.

🧬 Mechanism of Action 33 words ▾

12.1Mechanism of Action MPA Injectable Suspension, USP inhibits the secretion of gonadotropins which primarily prevents follicular maturation and ovulation and causes thickening of cervical mucus. These actions contribute to its contraceptive effect.

📦 How Supplied / Storage and Handling 19 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-5619 NDC: 50090-5619-0 1 mL in a VIAL / 1 in a CARTON

📋 Description ~1 min read ▾

11 DESCRIPTION Medroxyprogesterone Acetate Injectable Suspension, USP contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white; odorless crystalline powder that is stable in air and that melts between 200°C and 210°C.

It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and 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 as follows: MPA Injectable Suspension, USP for IM injection is available in vials and prefilled syringes, each containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL.

For MPA Injectable Suspension, USP vials, each mL of sterile aqueous suspension contains: Medroxyprogesterone acetate 150 mg Polyethylene glycol 3350 28.9 mg Polysorbate 80 2.41 mg Sodium chloride 8.68 mg Methylparaben 1.37 mg Propylparaben 0.150 mg Water for injection quantity sufficient When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both. For MPA Injectable Suspension, USP prefilled syringes, each mL of sterile aqueous suspension contains: Medroxyprogesterone acetate 150 mg Polyethylene glycol 3350 28.5 mg Polysorbate 80 2.37 mg Sodium chloride 8.56 mg Methylparaben 1.35 mg Propylparaben 0.147 mg Water for injection quantity sufficient When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

Chemical Structure

💬 Information for Patients 164 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA‑approved patient labeling (Patient Information). • Advise patients at the beginning of treatment that their menstrual cycle may be disrupted and that irregular and unpredictable bleeding or spotting results, and that this usually decreases to the point of amenorrhea as treatment with MPA Injectable Suspension, USP continues, without other therapy being required. • Counsel patients about the possible increased risk of breast cancer in women who use MPA Injectable Suspension, USP [see Warnings and Precautions (5.3) ]. • Counsel patients with a history of meningioma about the possible risk of worsening meningioma [see Warnings and Precautions (5.4) ]. • Counsel patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted infections. • Counsel patients on Warnings and Precautions associated with use of MPA Injectable Suspension, USP. • Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with MPA Injectable Suspension, USP.

🧬 Pharmacokinetics 214 words ▾

12.3Pharmacokinetics Absorption Following a single 150 mg IM dose of MPA Injectable Suspension, USP in eight women between the ages of 28 and 36 years old, medroxyprogesterone acetate concentrations, measured by an extracted radioimmunoassay procedure, increase for approximately 3 weeks to reach peak plasma concentrations of 1 to 7 ng/mL. Distribution Plasma protein binding of medroxyprogesterone acetate averages 86%. Medroxyprogesterone acetate binding occurs primarily to serum albumin.

No binding of medroxyprogesterone acetate occurs with sex-hormone-binding globulin (SHBG). Elimination Metabolism Medroxyprogesterone acetate is extensively metabolized in the liver by P450 enzymes. Its metabolism primarily involves ring A and/or side-chain reduction, loss of the acetyl group, hydroxylation in the 2-, 6-, and 21-positions or a combination of these positions, resulting in more than 10 metabolites.

Excretion The concentrations of medroxyprogesterone acetate decrease exponentially until they become undetectable (<100 pg/mL) between 120 to 200 days following injection. Using an unextracted radioimmunoassay procedure for the assay of medroxyprogesterone acetate in serum, the apparent half-life for medroxyprogesterone acetate following IM administration of MPA Injectable Suspension, USP is approximately 50 days. Most medroxyprogesterone acetate metabolites are excreted in the urine as glucuronide conjugates with only minor amounts excreted as sulfates.

Specific Populations The effect of hepatic and/or renal impairment on the pharmacokinetics of MPA Injectable Suspension, USP is unknown.

🧬 Pharmacodynamics 13 words ▾

12.2Pharmacodynamics No specific pharmacodynamic studies were conducted with MPA Injectable Suspension, USP.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Contraception In five clinical studies using MPA Injectable Suspension, USP, the 12-month failure rate for the group of women treated with MPA Injectable Suspension, USP was zero (no pregnancies reported) to 0.7 by Life-Table method. The effectiveness of MPA Injectable Suspension, USP is dependent on the patient returning every 3 months (13 weeks) for reinjection.

14.2Bone Mineral Density Changes in Women Treated with MPA Injectable Suspension, USP In a controlled, clinical study, adult women using MPA Injectable Suspension, USP (150 mg) for up to 5 years showed spine and hip bone mineral density (BMD) mean decreases of 5–6%, compared to no significant change in BMD in the control group. The decline in BMD was more pronounced during the first two years of use, with smaller declines in subsequent years. Mean changes in lumbar spine BMD of -2.86%, ‑4.11%, ‑4.89%, ‑4.93% and ‑5.38% after 1, 2, 3, 4, and 5 years, respectively, were observed.

Mean decreases in BMD of the total hip and femoral neck were similar. After stopping use of MPA Injectable Suspension, USP, there was partial recovery of BMD toward baseline values during the 2-year post-therapy period. Longer duration of treatment was associated with less complete recovery during this 2-year period following the last injection.

Table 4 shows the change in BMD in women after 5 years of treatment with MPA Injectable Suspension, USP and in women in a control group, as well as the extent of recovery of BMD for the subset of the women for whom 2-year post treatment data were available. Table 4. Mean Percent Change from Baseline in BMD in Adults by Skeletal Site and Cohort (5 Years of Treatment and 2 Years of Follow-Up) Time in Study Spine Total Hip Femoral Neck Medroxy-progesterone Acetate The treatment group consisted of women who received MPA Injectable Suspension, USP for 5 years and were then followed for 2 years post-use (total time in study of 7 years).

Control The control group consisted of women who did not use hormonal contraception and were followed for 7 years. Medroxy-progesterone Acetate Control Medroxy-progesterone Acetate Control 5 years -5.38% n=33 0.43% n=105 -5.16% n=21 0.19% n=65 -6.12% n=34 -0.27% n=106 7 years -3.13% n=12 0.53% n=60 -1.34% n=7 0.94% n=39 -5.38% n=13 -0.11% n=63

14.3Bone Mineral Density Changes in Adolescent Females (12 to 18 Years of Age) Treated with MPA Injectable Suspension, USP The impact of MPA Injectable Suspension, USP (150 mg) use for up to 240 weeks (4.6 years) was evaluated in an open-label non-randomized clinical study in 389 adolescent females (12 to 18 years of age). Use of MPA Injectable Suspension, USP was associated with a significant decline from baseline in BMD. Partway through the trial, drug administration was stopped (at 120 weeks).

The mean number of injections per MPA Injectable Suspension, USP user was 9.3. Table 5 summarizes the study findings. The decline in BMD at total hip and femoral neck was greater with longer duration of use.

The mean decrease in BMD at 240 weeks was more pronounced at total hip (-6.4%) and femoral neck (-5.4%) compared to lumbar spine (-2.1%). Adolescents in the untreated cohort had an increase in BMD during the period of growth following menarche. However, the two cohorts were not matched at baseline for age, gynecologic age, race, BMD and other factors that influence the rate of acquisition of BMD.

Table 5. BMD Mean Percent Change from Baseline in Adolescents Receiving ≥4 Injections per 60-week Period, by Skeletal Site and Cohort Duration of Treatment MPA Injectable Suspension, USP (150 mg IM) Unmatched, Untreated Cohort N Mean % Change N Mean % Change Total Hip BMD Week 60 (1.2 years) 113 -2.75 166

1.22Week 120 (2.3 years) 73 -5.40 109

2.19Week 240 (4.6 years) 28 -6.40 84

1.71Femoral Neck BMD Week 60 113 -2.96 166

1.75Week 120 73 -5.30 108

2.83Week 240 28 -5.40 84

1.94Lumbar Spine BMD Week 60 114 -2.47 167

3.39Week 120 73 -2.74 109

5.28Week 240 27 -2.11 84… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 24 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [see Warnings and Precautions (5.3 , 5.15 ) and Use in Specific Populations (8.3) ].

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 21 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [see Warnings and Precautions (5.3 , 5.15 ) and Use in Specific Populations (8.3) ].

📚 References 51 words ▾

15 REFERENCES 1. Li CI, Beaber EF, Tang, MCT et al. Effect of Depo-Medroxyprogesterone Acetate on Breast Cancer Risk among Women 20 to 44 years of Age. Cancer Research 2012; 72:2028–2035. 2. Paul C, Skegg DCG, Spears GFS. Depot medroxyprogesterone (Depo-Provera) and risk of breast cancer. Br Med J 1989; 299:759–62.

📄 Patient Package Insert ~3 min read ▾

Patient Information Medroxyprogesterone Acetate Injectable Suspension, USP Contraceptive Injection Read this Patient Information carefully before you decide if Medroxyprogesterone Acetate (MPA) Injectable Suspension, USP is right for you. This information does not take the place of talking with your gynecologist or other healthcare professional who specializes in women's health. If you have any questions about MPA Injectable Suspension, USP, ask your healthcare professional.

You should also learn about other birth control methods to choose the one that is best for you. What is the most important information I should know about MPA Injectable Suspension, USP? MPA Injectable Suspension, USP can cause serious side effects, including: • Use of MPA Injectable Suspension, USP may cause you to lose calcium stored in your bone and decrease your bone mass.

The longer you use MPA Injectable Suspension, USP, the greater your loss of calcium from your bones. Your bones may not recover completely when you stop using MPA Injectable Suspension, USP. • If you use MPA Injectable Suspension, USP continuously for a long time (for more than 2 years), it may increase the risk of weak, porous bones (osteoporosis) that could increase the risk of broken bones, especially after menopause. • You should not use MPA Injectable Suspension, USP for more than two years unless you cannot use other birth control methods. • It is not known if your risk of developing osteoporosis is greater if you are a teenager or young adult when you start to use MPA Injectable Suspension, USP.

(see " What are the possible side effects of MPA Injectable Suspension, USP? "). MPA Injectable Suspension, USP is intended to prevent pregnancy. MPA Injectable Suspension, USP does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs).

What is MPA Injectable Suspension, USP? MPA Injectable Suspension, USP is a progestin hormone birth control method that is given by injection (a shot) to prevent pregnancy. How well does MPA Injectable Suspension, USP work?

Your chance of getting pregnant depends on how well you follow the directions for taking your MPA Injectable Suspension, USP. The more carefully you follow the directions (such as returning every 3 months for your next injection), the less chance you have of getting pregnant. In clinical studies, about 1 out of 100 women got pregnant during the first year that they used MPA Injectable Suspension, USP.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart.

The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. How should I take MPA Injectable Suspension, USP? • MPA Injectable Suspension, USP is given by your healthcare professional as a shot into your muscle (intramuscular injection). The shot is given in your buttock or upper arm 1 time every 3 months.

At the end of the 3 months, you will need to return to your healthcare professional for your next injection in order to continue your protection against pregnancy. • To make sure that you are not pregnant before you take MPA Injectable Suspension, USP, the first injection should be given only: o during the first 5 days of a normal menstrual period, or o within the first 5 days after giving birth, if you are not breastfeeding , or o at the 6th week after giving birth, if you are feeding your baby only breastmilk. • MPA Injectable Suspension, USP may be given at other times than those listed above, but you will likely need to have a pregnancy test first to show that you are not pregnant. • During treatment with MPA Injectable Suspension, USP, you should see your healthcare professional every year for a blood pressure check and other healthcare needs.

Who Shoul… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 8 words ▾

Warnings and Precautions, Meningioma ( 5.4 ) 12/2025

📄 Package Label / Principal Display Panel 4 words ▾

MEDROXYPROGESTERONE ACETATE Label Image

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.

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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 A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
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A-S Medication Solutions 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.
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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.
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← 50090-5617-00 · A-S 50090-5625-00 · A-S →
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.