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Medroxyprogesterone Acetate 150 mg/mL Injection, Suspension, Extended Release, 25 vials — NDC 0548-5410-25 (Billing 00548-5410-25)

by Amphastar Pharmaceuticals, Inc. · 25 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 25 vials of Medroxyprogesterone Acetate 150 mg/mL Injection, Suspension, Extended Release from Amphastar Pharmaceuticals, Inc., no longer marketed (first marketed Nov 2017), no longer in the FDA NDC Directory; retail pharmacies pay about $30.77 per mL (NADAC).

NDC 00548-5410-25
🏷️ FDA NDC (as labeled) 0548-5410-25 billing pads the labeler segment with a zero
This package
Contains25 vials Cost per mL$30.77 NADAC Per package$769.31 / 25 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $23.56/unit · Part D plans $27.44/unit — full pricing hub ↓
Product page 00548-5410-00 Also comes in: 1 mL 0548-5410-00
Rx only Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through May 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0548-5410-25
Product NDC 0548-5410
11-digit billing NDC 00548541025
NCPDP billing unit ML — per mL (volume)
RxCUI 1000126, 1000153
UNII C2QI4IOI2G
Application # ANDA077235
SPL Set ID e364a31e-8926-4bda-b00e-efb097bd3830
Established class (EPC) Progestin
Chemical class Progesterone Congeners
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through May 2025)
Marketing start 2017-11-28
Route INTRAMUSCULAR
Dosage form INJECTION, SUSPENSION, EXTENDED RELEASE
Substance MEDROXYPROGESTERONE ACETATE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 25150035101820
GPI class medroxyPROGESTERone Acetate
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
  • GPI-14 (Medi-Span): 25150035101820
  • HICL (First Databank): 001442
  • AHFS class code: 68:32.00.00
  • RxCUI (RxNorm): 1000126
Why two NDCs? The FDA registers this code as 0548-5410-25 — a 4-4-2 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 labeler segment → 00548-5410-25. 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 $30.772 $769.31 / 25 ml
Medicaid paysCMS SDUD · 12 mo $23.56 $589.05 / 25 ml
Medicare drug plans payPart D · Q2 2026 $27.44 $685.90 / 25 ml
Medicare Part B allowsASP · J1050 No ASP payment limit on file for J1050 this quarter.
NADAC price history (per mL) — tap or hover for the price & month
Sep 2021 $30.772 $30.772
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.

Billing & reimbursement

FDA NDC (as labeled)0548-5410-25
11-digit billing NDC00548-5410-25
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1050
DescriptorINJECTION, MEDROXYPROGESTERONE ACETATE, 1 MG
Billing units / pkg150 units
How the units are derivedThis package is 1 ML; the HCPCS unit is 1 MG, so one package = 150 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00548-5410-00 0548-5410-00 Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE $26.22 / mL $26.22 2019-05-01 — Discontinued by firm
00548-5410-25 You're viewing this 25 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE $30.77 / mL $769.31 2019-05-01 — Discontinued by firm

Per mL, this pack runs about 17% above the cheapest pack (NDC 00548-5410-00, $26.22 vs $30.77 NADAC).

This pack accounts for about 24% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 25 vials — 25 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose.
How does this package differ from NDC 00548-5410-00?
Both are Medroxyprogesterone Acetate 150 mg/mL Injection, Suspension, Extended Release — the drug itself is identical. This page's package is the 25 vials one, while NDC 00548-5410-00 is the 1 vial package. Per-mL NADAC also differs: $30.77 here vs $26.22 for the 1 vial pack.
What NDC number is used to bill for this package of Medroxyprogesterone Acetate 150 mg/mL Injection, Suspension, Extended Release?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Medroxyprogesterone Acetate 150 mg/mL 00548-5400-00 Amphastar 1 vial $18.854 AB Availability likely save 39%
Medroxyprogesterone Acetate 150 mg/mL 55150-0329-01 Eugia 1 vial $18.854 AB Availability likely save 39%
Medroxyprogesterone Acetate 150 mg/mL 60219-1467-01 Amneal 1 vial $18.854 AB Availability likely save 39%
medroxyprogesterone acetate 150 mg/mL 70121-1467-02 Amneal 1 vial $18.854 AB Availability likely save 39%
Medroxyprogesterone Acetate 150 mg/mL 70700-0315-22 Xiromed 1 ml $18.854 AB Availability likely save 39%
medroxyprogesterone acetate 150 mg/mL 66993-0370-25 Prasco 25 vials $22.850 AB Availability likely save 26%
Medroxyprogesterone Acetate 150 mg/mL 67457-0887-01 Mylan 25 vials $22.850 AB Availability likely save 26%
Medroxyprogesterone Acetate 150 mg/mL 62756-0090-40 Sun 1 vial $26.215 — FDA listed save 15%
Medroxyprogesterone Acetate 150 mg/mL 00548-5701-00 Amphastar 1 syringe $27.364 AB Availability likely save 11%
medroxyprogesterone acetate 150 mg/mL 66993-0371-79 Prasco 1 syringe $27.364 AB Availability likely save 11%
medroxyprogesterone acetate 150 mg/mL 70121-1480-01 Amneal 1 syringe $27.364 AB Availability likely save 11%
Medroxyprogesterone Acetate 150 mg/mL 55150-0330-01 Eugia 1 syringe $27.364 AB Availability likely save 11%
Medroxyprogesterone Acetate 150 mg/mLthis 00548-5410-25 Amphastar 25 vials $30.772 AB Discontinued —
Medroxyprogesterone Acetate 150 mg/mL 00548-5711-00 Amphastar 1 syringe $38.621 AB Discontinued +26%
Medroxyprogesterone Acetate 150 mg/mL 62756-0091-40 Sun 1 syringe $38.621 — FDA listed +26%
Depo-Provera 150 mg/mL 00009-0746-30 Pharmacia 1 vial $50.994 AB Availability likely +66%
Depo-Provera 150 mg/mL 00009-7376-11 Pharmacia 1 syringe $52.335 AB Availability likely +70%
Medroxyprogesterone Acetate Injectable Suspension 150 mg/mL 24201-0150-01 Hikma 1 vial — — FDA listed —
medroxyprogesterone acetate 150 mg/mL 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 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

🏛️
2017
On the market since
Nov 2017
📍
2026
Currently FDA-listed
9 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.

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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
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

LabelerAmphastar Pharmaceuticals, Inc.
Application holderAMPHASTAR PHARMACEUTICALS INC
FDA applicationANDA077235 (ANDA)
Labeler code00548
First marketedNov 2017
Product typeHuman Prescription Drug
Portfolio24 products on file
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 📦 Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 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 217 words ▾

WARNING: LOSS OF BONE MINERAL DENSITY Women who use Medroxyprogesterone acetate Contraceptive Injection may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. It is unknown if use of Medroxyprogesterone acetate Contraceptive Injection 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.

Medroxyprogesterone acetate Contraceptive Injection should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate. [See Warnings and Precautions (5.1) ]. WARNING: LOSS OF BONE MINERAL DENSITY See full prescribing information for complete boxed warning. Women who use Medroxyprogesterone acetate Contraceptive Injection 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 Medroxyprogesterone acetate Contraceptive Injection 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 ) Medroxyprogesterone acetate Contraceptive Injection should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate.

( 5.1 )

🎯 Indications and Usage 83 words ▾

1 INDICATIONS AND USAGE Medroxyprogesterone acetate is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Medroxyprogesterone acetate long-term [see Warnings and Precautions (5.1) ] . Medroxyprogesterone acetate is a progestin indicated only for the prevention of pregnancy.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION The recommended dose is 150 mg of Medroxyprogesterone acetate 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 Medroxyprogesterone acetate 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 Medroxyprogesterone acetate 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.

Medroxyprogesterone acetate should not be used as a long-term birth control method (i.e. longer than 2 years) unless other birth control methods are considered inadequate. 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; ONLY within the first 5-days postpartum if not breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum 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 Medroxyprogesterone acetate depends on adherence to the dosage schedule of administration.

2.2Switching from other Methods of Contraception When switching from other contraceptive methods, Medroxyprogesterone acetate 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 Medroxyprogesterone acetate on the day after the last active tablet or at the latest, on the day following the final inactive tablet).

💊 Dosage Forms and Strengths 61 words ▾

3 DOSAGE FORMS AND STRENGTHS Sterile Aqueous suspension: 150 mg/ml Prefilled syringes are available packaged with a 22-gauge × 1 1/2 inch Needle Pro ® EDGE™ Safety Device. Vials containing sterile aqueous suspension: 150 mg per mL ( 3 ) Prefilled syringes: prefilled syringes are available packaged with 22-gauge × 1 1/2 inch Needle-Pro ® EDGE™ Safety Device ( 3 )

⛔ Contraindications 162 words ▾

4 CONTRAINDICATIONS The use of Medroxyprogesterone acetate is contraindicated in the following conditions: Known or suspected pregnancy or as a diagnostic test for pregnancy. Active thrombophlebitis, or current or past 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 Medroxyprogesterone acetate or any of its other ingredients [see Warnings and Precautions (5.5) ] . Significant liver disease [see Warnings and Precautions (5.6) ]. Undiagnosed vaginal bleeding [see Warnings and Precautions (5.9) ] .

Known or suspected pregnancy or as a diagnostic test for pregnancy. ( 4 ) 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 Medroxyprogesterone acetate (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 Medroxyprogesterone acetate in patients who develop thrombosis ( 5.2 ) Cancer Risks: Monitor women with a strong family history of breast cancer carefully. ( 5.3 ) Ectopic Pregnancy: Consider ectopic pregnancy if a woman using Medroxyprogesterone acetate becomes pregnant or complains of severe abdominal pain. ( 5.4 ) Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment.

( 5.5 ) Liver Function: Discontinue Medroxyprogesterone acetate if jaundice or disturbances of liver function develop. ( 5.6 ) Carbohydrate Metabolism: Monitor diabetic patients carefully. ( 5.11 )

5.1Loss of Bone Mineral Density Use of Medroxyprogesterone acetate 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 Medroxyprogesterone acetate by younger women will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.

After discontinuing Medroxyprogesterone acetate in adolescents, mean BMD loss at total hip and femoral neck did not fully recover by 60 months (240 weeks) post-treatment [see Clinical Studies (14.3) ] . Similarly, in adults, there was only partial recovery of mean BMD at total hip, femoral neck and lumbar spine towards baseline by 24 months post-treatment. [See Clinical Studies (14.2) .] Medroxyprogesterone acetate should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate.

BMD should be evaluated when a woman needs to continue to use Medroxyprogesterone acetate 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 Medroxyprogesterone acetate in women with osteoporosis risk factors.

Medroxyprogesterone acetate 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). Although there are no studies addressing whether calcium and Vitamin D may lessen BMD loss in women using Medroxyprogesterone acetate, all patients should have adequate calcium and Vitamin D intake.

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

Do not readminister Medroxyprogesterone acetate 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 readminister 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 Medroxyprogesterone acetate, 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 1, 2, 3, 4, 5 assessing the association between depomedroxyprogesterone acetate (DMPA) use and the risk of breast cancer are summarized in Figure 1.

Three of the studies suggest a slightly increased risk of breast cancer in the overall population of users; these increased risks were statistically significant in one study. One… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions observed with the use of Medroxyprogesterone acetate 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 (5.5) ] Bleeding Irregularities [see Warnings and Precautions (5.10) ] Weight Gain [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence >5%) are: menstrual irregularities (bleeding or spotting) 57% at 12 months, 32% at 24 months, abdominal pain/discomfort 11%, weight gain > 10 lbs at 24 months 38%, dizziness 6%, headache 17%, nervousness 11%, decreased libido 6%.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc. at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, 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 Medroxyprogesterone acetate, 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 Medroxyprogesterone acetate.

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 Medroxyprogesterone acetate 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 lbs at 24 months (37.7%) Nervous Nervousness (10.8%) Dizziness (5.6%) Libido decreased (5.5%) Urogenital 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%) Urogenital 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 Medroxyprogesterone acetate. 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 Medroxyprogesterone acetate.

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 infection†, Injection site nodule/lump, Injection site pain/tenderness, Injection site persistent atrophy/indentation/dimpling, Inj… [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 Medroxyprogesterone acetate. ( 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 Medroxyprogesterone acetate: (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 ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS Nursing Mothers: Detectable amounts of drug have been identified in the milk of mothers receiving Medroxyprogesterone acetate. ( 8.3 ) Pediatric Patients: Medroxyprogesterone acetate is not indicated before menarche. ( 8.4 )

8.1Pregnancy Medroxyprogesterone acetate should not be administered during pregnancy. [See Contraindications and Warnings and Precautions (5.17) .]

8.3Nursing Mothers Detectable amounts of drug have been identified in the milk of mothers receiving Medroxyprogesterone acetate. [See Warnings and Precautions (5.13) .]

8.4Pediatric Use Medroxyprogesterone acetate is not indicated before menarche. Use of Medroxyprogesterone acetate 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 Medroxyprogesterone acetate 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.

8.6Renal Impairment The effect of renal impairment on Medroxyprogesterone acetate pharmacokinetics has not been studied.

8.7Hepatic Impairment The effect of hepatic impairment on Medroxyprogesterone acetate pharmacokinetics has not been studied. Medroxyprogesterone acetate should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur. [See Contraindications (4) and Warnings and Precautions (5.7) .]

🤰 Pregnancy 18 words ▾

8.1Pregnancy Medroxyprogesterone acetate should not be administered during pregnancy. [See Contraindications and Warnings and Precautions (5.17) .]

🧒 Pediatric Use 104 words ▾

8.4Pediatric Use Medroxyprogesterone acetate is not indicated before menarche. Use of Medroxyprogesterone acetate 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 Medroxyprogesterone acetate 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 Medroxyprogesterone acetate (MPA), when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect.

12.2Pharmacodynamics No specific pharmacodynamic studies were conducted with Medroxyprogesterone acetate.

12.3Pharmacokinetics Absorption Following a single 150 mg IM dose of Medroxyprogesterone acetate 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 MPA averages 86%. MPA binding occurs primarily to serum albumin.

No binding of MPA occurs with sex-hormone-binding globulin (SHBG). Metabolism MPA 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 Medroxyprogesterone acetate 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 Medroxyprogesterone acetate is unknown.

🧬 Mechanism of Action 42 words ▾

12.1Mechanism of Action Medroxyprogesterone acetate (MPA), when administered at the recommended dose to women every 3 months, inhibits the secretion of gonadotropins which, in turn, prevents follicular maturation and ovulation and results in endometrial thinning. These actions produce its contraceptive effect.

📦 How Supplied / Storage and Handling ~3 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL is available as: NDC 0548-5410-00 1 mL single dose vial Stock No. 5410 The 1 mL dose vials are packaged in individual cartons. NDC 0548-5410-25 1 mL single dose vial Stock No.

5411 The 1 mL dose vials are packaged with 25 vials per carton. NDC 0548-5711-00 1 mL single dose syringe Stock No. 5711 The 1 mL dose syringes are packaged in individual cartons.

Each syringe is packaged with a 22 gauge × 1 1/2 inch needle with the Needle-Pro ® EDGE TM Safety Device. Instructions for using the Needle: 1. WARNINGS for use with the Needle-Pro ® EDGE™ Safety Device:

1.1A needle stick with a contaminated needle may cause infectious diseases.

1.2Intentional disengagement of the Needle-Pro ® EDGE™ safety device may result in a needle stick with a contaminated needle.

1.3Bent or damaged needles can result in breakage or damage to the tissue or accidental needle puncture. If the needle is bent or damaged, no attempt should be made to straighten the needle or engage the Needle-Pro ® EDGE™ safety device. Immediately discard into a sharps container.

The Needle-Pro ® EDGE™ safety device may not properly contain a bent needle and/or the needle could puncture the needle protection device which may result in a needle stick with a contaminated needle.

1.4Mishandling of this device, including excessive engagement force, may cause the needle to protrude from the needle protection device which may result in a contaminated needle stick.

1.5Do not use free hand to press sheath over the needle. This may result in a needle stick with a contaminated needle. 2. CAUTIONS for use with the Needle-Pro ® EDGE™ Safety Device:

2.1Follow standard infection control procedures as specified by the Centers for Disease Control and Prevention (USA) or local equivalent.

2.2Do Not Reuse: Medical devices require specific material characteristics to perform as intended. These characteristics have been verified for single use only. Any attempt to re-process the device for subsequent reuse may adversely affect the integrity of the device or lead to deterioration in performance. 3. INSTRUCTIONS for use of the Prefilled Syringe with the Needle-Pro ® EDGE™ Safety Device:

3.1Remove syringe end cap exposing the luer fitting. Peel blister pouch for the Needle-Pro ® EDGE™ safety device open half way. Grasp sheath using the plastic peel pouch. To prevent contamination, be careful not to touch the needle’s Luer connector.

3.2Attach prefilled syringe to the Luer connection of the Needle-Pro ® EDGE™ safety device. Insert plunger rod into open end of syringe until it contacts the stopper. Secure with 3 clockwise half turns. Shake vigorously with needle cap in place.

3.3Pull needle cap (plastic component covering needle) straight away from the needle. Do not twist cap as Needle-Pro ® EDGE™ safety device may be loosened from the prefilled syringe.

3.4For user convenience, the needle is in the “bevel up” position when the safety sheath is located to the right as indicated by the “arrow” on the device.

3.5Perform injection according to local standard practice using aseptic technique.

3.6After procedure is completed, actuate needle protection by pressing the sheath against a flat surface using a one-handed technique. An audible click may be heard as an indication that the needle is engaged into the needle protection device. AS THE SHEATH IS PRESSED (FIGURE 1), THE NEEDLE IS FIRMLY ENGAGED INTO THE SHEATH (FIGURE 2).

3.7Visually confirm that the needle is fully engaged into the needle protection sheath.

3.8After use, place syringe and needle into a sharps container. Dispose of sharps container containing used syringe and needle in a safe manner according to Centers for Disease Control and Prevention, USA and Federal/State/Local regulations (EPA, OSHA) and health care facility guidelines or local equivalent. The Smiths Medical and Jelco design marks; Needle-Pro ® EDGE; and the color… [Excerpted — this section continues on DailyMed.]

📦 Storage and Handling 39 words ▾

Syringe must be stored in carton at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] until ready for use. Vials MUST be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

📋 Description 159 words ▾

11 DESCRIPTION Medroxyprogesterone acetate 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: Medroxyprogesterone acetate for intramuscular (IM) injection is available in vials and prefilled syringes, each containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL.

Each mL 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. structure

💬 Information for Patients 126 words ▾

17 PATIENT COUNSELING INFORMATION "See 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 Medroxyprogesterone acetate continues, without other therapy being required. Counsel patients about the possible increased risk of breast cancer in women who use Medroxyprogesterone acetate [see Warnings and Precautions (5.3) ].

Counsel patients that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Counsel patients on Warnings and Precautions associated with use of Medroxyprogesterone acetate. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with Medroxyprogesterone acetate.

🍼 Nursing Mothers 24 words ▾

8.3Nursing Mothers Detectable amounts of drug have been identified in the milk of mothers receiving Medroxyprogesterone acetate. [See Warnings and Precautions (5.13) .]

🧬 Pharmacokinetics 203 words ▾

12.3Pharmacokinetics Absorption Following a single 150 mg IM dose of Medroxyprogesterone acetate 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 MPA averages 86%. MPA binding occurs primarily to serum albumin.

No binding of MPA occurs with sex-hormone-binding globulin (SHBG). Metabolism MPA 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 Medroxyprogesterone acetate 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 Medroxyprogesterone acetate is unknown.

🧬 Pharmacodynamics 11 words ▾

12.2Pharmacodynamics No specific pharmacodynamic studies were conducted with Medroxyprogesterone acetate.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

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

14.2Bone Mineral Density (BMD) Changes in Adult Women In a controlled, clinical study, adult women using Medroxyprogesterone acetate for up to 5 years showed spine and hip 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 Medroxyprogesterone acetate (150 mg), 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 Medroxyprogesterone acetate 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 Medroxyprogesterone acetate The treatment group consisted of women who received Medroxyprogesterone acetate 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. Medroxyprogesterone acetate Control Medroxyprogesterone 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 (12–18 years of age) The impact of Medroxyprogesterone acetate (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 (12–18 years). Use of Medroxyprogesterone acetate 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 Medroxyprogesterone acetate user was 9.3. The decline in BMD at total hip and femoral neck was greater with longer duration of use (see Table 5 ). 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%).

In general, adolescents increase bone density during the period of growth following menarche, as seen in the untreated cohort. 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 bone mineral density. Table 5.

Mean Percent Change from Baseline in BMD in Adolescents Receiving ≥ 4 Injections per 60-week Period, by Skeletal Site and Cohort Duration of Treatment Medroxyprogesterone acetate (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

6.40BMD recovery post-treatment in adolescent women Longer duration of treatment and smoking were associated with less recovery of… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 20 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [See Warnings and Precautions, (5.3 , 5.14 , and 5.16 ).]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 17 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [See Warnings and Precautions, (5.3 , 5.14 , and 5.16 ).]

📚 References 134 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. Shapiro S, Rosenberg L, Hoffman M et al.

Risk of Breast Cancer in Relation to the Use of Injectable Progestogen Contraceptives and Combined Estrogen/Progestogen Contraceptives. Am J Epidemiol 2000:Vol.151, No. 4, 396-403.

3. WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Breast cancer and depot-medroxyprogesterone acetate: a multinational study.

Lancet 1991; 338:833-38 4. Paul C, Skegg DCG, Spears GFS. Depot medroxyprogesterone (Depo-Provera) and risk of breast cancer.

Br Med J 1989; 299:759-62. 5. Lee NC, Rosero-Bixby L, Oberle MW et al.

A Case-Control Study of Breast Cancer and Hormonal Contraception in Costa Rica. JNCI 1987; 79:1247-1254 6. http://seer.cancer.gov/faststats/index.php (Accessed on August 14, 2014)

📄 Patient Package Insert ~3 min read ▾

Patient Information Medroxyprogesterone acetate (medroxyprogesterone acetate injectable suspension) Contraceptive Injection Read this Patient Information carefully before you decide if Medroxyprogesterone acetate is right for you. This information does not take the place of talking with your gynecologist or other healthcare provider who specializes in women’s health. If you have any questions about Medroxyprogesterone acetate, ask your healthcare provider.

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 Medroxyprogesterone acetate? Medroxyprogesterone acetate can cause serious side effects, including: • Use of Medroxyprogesterone acetate may cause you to lose calcium stored in your bone and decrease your bone mass.

The longer you use Medroxyprogesterone acetate, the greater your loss of calcium from your bones. Your bones may not recover completely when you stop using Medroxyprogesterone acetate. • If you use Medroxyprogesterone acetate 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 Medroxyprogesterone acetate 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 Medroxyprogesterone acetate (see “What are the possible side effects of Medroxyprogesterone acetate?”).

Medroxyprogesterone acetate is intended to prevent pregnancy. Medroxyprogesterone acetate does not protect against HIV infection (AIDS) and other sexually transmitted diseases (STDs). What is Medroxyprogesterone acetate?

Medroxyprogesterone acetate is a progestin hormone birth control method that is given by injection (a shot) to prevent pregnancy. How well does Medroxyprogesterone acetate work? Your chance of getting pregnant depends on how well you follow the directions for taking your Medroxyprogesterone acetate.

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 Medroxyprogesterone acetate. 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 Medroxyprogesterone acetate? Medroxyprogesterone acetate is given by your healthcare provider 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 provider for your next injection in order to continue your protection against pregnancy. •To make sure that you are not pregnant before you take Medroxyprogesterone acetate, 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. •Medroxyprogesterone acetate 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 Medroxyprogesterone acetate, you should see your healthcare provider every year for a blood pressure check and other healthcare needs.

Who Should Not Use Medroxyprogesterone acetate? Do not use Medroxyprogesterone acetate if you: • are pregnant or th… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 20 words ▾

Dosage and Administration, Prevention of Pregnancy ( 2.1 ) 11/2016 Warnings and Precautions, Injection Site Reactions ( 5.6 ) 11/2016

📄 Package Label / Principal Display Panel 173 words ▾

Unit Carton - Stock No. 5410 PRINCIPAL DISPLAY PANEL TEXT: NDC 0548-5410-00 Stock No. 5410 MedroxyPROGESTERone ACETATE INJECTABLE SUSPENSION, USP 150 mg (150 mg/mL) Rx Only One 1 mL Single-Dose Vial For Intramuscular Use Only Each mL contains: Medroxyprogesterone acetate, 150 mg.

Also polyethylene glycol 3350, 28.9 mg; polysorbate 80, 2.41 mg; sodium chloride, 8.68 mg; and added as preservatives, methylparaben, 1.37 mg; propylparaben, 0.150 mg. When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Usual Dosage: See package insert for complete product information.

Store at 20°-25°C (68°-77°F), [See USP Controlled Room Temperature]. Shake vigorously immediately before use. single-pack-vial-carton

25-Pack Carton - Stock No. 5411 PRINCIPAL DISPLAY PANEL TEXT: NDC 0548-5410-25 Rx Only MedroxyPROGESTERone ACETATE INJECTABLE SUSPENSION, USP 150 mg/mL 25 x 1 mL Single-Dose Vials For Intramuscular Use Only. Stock No. 5411 5254116A/4-18 25-pack-vial-carton

Unit Carton - Stock No. 5711 PRINCIPAL DISPLAY PANEL TEXT: NDC 0548-5711-00 MedroxyPROGESTERone ACETATE INJECTABLE SUSPENSION, USP 150 mg (150 mg/mL) 1 mL Prefilled Syringe Rx Only For Intramuscular Use Only Single Use Syringe image description

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
38
Units reimbursed last 4 qtrs
38
Gross reimbursed last 4 qtrs
$895.36
Avg / prescription
$23.56
Avg / unit
$23.5621
Latest quarter Q4 2025
0Rx
Medicaid pays / mL
$23.5621
gross reimbursed
vs
NADAC / mL
$30.7723
acquisition cost
=
Spread
−$7.2102
-23% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
61% FFS 39% MCO
Fee-for-service · 23 Rx Managed care · 15 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 15 units · 0.1 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 23 units · 0.4 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.10.4
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Missouri 0.4 /100k
2 Ohio 0.1 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 vial00548-5410-00 120 Rx · $8,515
25 vials this page00548-5410-25 38 Rx · $895
Drug total (last 4 qtrs): 158 Rx · 154 units · $9,410 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 vial (00548-5410-00). 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?
Amphastar Pharmaceuticals, 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J1050 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 00548-5400-00 · Amphastar 00548-5601-00 · Amphastar →
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.