Depo-Provera medroxyprogesterone acetate 150 mg/mL Injection, Suspension, 25 vials — NDC 0009-0746-35 (Billing 00009-0746-35)
This is a package of 25 vials of Depo-Provera medroxyprogesterone acetate 150 mg/mL Injection, Suspension from Pharmacia & Upjohn Company LLC, marketed since Oct 1992 and currently FDA-listed.
Other active recalls for Medroxyprogesterone Acetate (different manufacturers) — 1 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 017584
- GCN: 11251
- HICL (First Databank): 001442
- AHFS class code: 68:32.00.00
- RxCUI (RxNorm): 1000126
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Progestin class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Medroxyprogesterone injection is used to prevent pregnancy and to treat endometriosis (a condition in which the type of tissue that lines the uterus (womb) grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Medroxyprogesterone is in a class of medications called progestins. It works to prevent pregnancy by preventing ovulation (the release of eggs from the ovaries). Medroxyprogesterone also thins the lining of the uterus which helps to prevent pregnancy in all women and slows the spread of tissue from the uterus to other parts of t...
Read the full MedlinePlus article ↗- 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Medroxyprogesterone Acetate — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $45.44 | $1,135.90 / 25 ml |
| Medicare drug plans payPart D · Q2 2026 | $52.82 | $1,320.54 / 25 ml |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 00009-0746-30 0009-0746-30 Main listing | 1 VIAL in 1 CARTON / 1 mL in 1 VIAL | $50.99 / mL | $50.99 | 1992-10-29 | — | Active |
| 00009-0746-35 You're viewing this | 25 VIAL in 1 PACKAGE / 1 mL in 1 VIAL | — | — | 1992-10-29 | — | Active |
This pack accounts for about 17% 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?
How does this package differ from NDC 00009-0746-30?
What NDC number is used to bill for this package of Depo-Provera medroxyprogesterone acetate 150 mg/mL Injection, Suspension?
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 00009-7376-11 | Pharmacia | 1 syringe | $52.335 | AB | Availability likely | — |
| Depo-Provera 150 mg/mLthis 00009-0746-35 | Pharmacia | 25 vials | — | AB | FDA listed | — |
| 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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1.37 mg / 1 mL
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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28.9 mg / 1 mL
UNII G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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2.41 mg / 1 mL
UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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0.15 mg / 1 mL
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
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8.68 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
8 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: LOSS OF BONE MINERAL DENSITY • Women who use Depo-Provera Contraceptive Injection (Depo-Provera CI) 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 Depo-Provera CI 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) ] . • Depo-Provera CI 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 Depo-Provera Contraceptive Injection (Depo-Provera CI) 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 Depo-Provera CI 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 ) • Depo-Provera CI 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 ▾
1 INDICATIONS AND USAGE Depo-Provera CI is indicated for use by females of reproductive potential to prevent pregnancy. Depo-Provera CI is a progestin indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Use: The use of Depo-Provera CI 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 Depo-Provera CI 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 DOSAGE AND ADMINISTRATION The recommended dose is 150 mg of Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI 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 Depo‑Provera CI 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 Depo-Provera CI depends on adherence to the dosage schedule of administration.
2.2Switching from Other Methods of Contraception When switching from other contraceptive methods, Depo-Provera CI 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 Depo-Provera CI on the day after the last active tablet or at the latest, on the day following the final inactive tablet).
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Sterile Aqueous suspension: 150 mg/mL Prefilled syringes are available packaged with 22-gauge x 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 x 1 1/2 inch Terumo® SurGuard™ Needles. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS The use of Depo-Provera CI 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 Depo-Provera CI (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 Depo-Provera CI (medroxyprogesterone acetate or any of its other ingredients). ( 4 ) • Significant liver disease.
( 4 ) • Undiagnosed vaginal bleeding. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Thromboembolic Disorders: Discontinue Depo-Provera CI in patients who develop thrombosis. ( 5.2 ) • Cancer Risks: Monitor women with a strong family history of breast cancer carefully. ( 5.3 ) • Meningioma: Discontinue Depo-Provera CI if meningioma is diagnosed.
Monitor patients for signs and symptoms of meningioma. ( 5.4 ) • Ectopic Pregnancy: Consider ectopic pregnancy if a woman using Depo-Provera CI becomes pregnant or complains of severe abdominal pain. ( 5.5 ) • Anaphylaxis and Anaphylactoid Reactions: Provide emergency medical treatment.
( 5.6 ) • Liver Function: Discontinue Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI. After discontinuing Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI in women with osteoporosis risk factors. Depo-Provera CI 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 Depo-Provera CI (150 mg). However, Depo-Provera CI has not been causally associated with the induction of thrombotic or thromboembolic disorders. Any patient who develops thrombosis while undergoing therapy with Depo-Provera CI should discontinue treatment unless she has no other acceptable options for birth control.
Do not re-administer Depo-Provera CI 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 Depo-Provera CI, 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 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 recent US study 1 evaluated the recency and duration of use and f… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following important adverse reactions observed with the use of Depo-Provera CI 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 Pfizer Inc. at 1-800-438-1985 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 Depo-Provera CI, 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 Depo-Provera CI. 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 Depo-Provera CI 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 ) 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 ) 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 Depo-Provera CI. 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 Depo-Provera CI.
Table 3. Adverse Reactions Reported during Post-Marketing Experience Body System* 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, Injection-site reaction, Lipodystrophy acquired, Chills, Axillary swelling Cardiovascular Syncope, Tac… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
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 Depo-Provera CI. ( 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 Depo-Provera CI: (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 ▾
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 Depo-Provera CI. ( 8.2 ) • Pediatric Patients: Depo-Provera CI is not indicated before menarche. ( 8.4 )
8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, Depo-Provera CI 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 Depo-Provera CI, 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 Depo-Provera CI 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 Depo-Provera CI and any potential adverse effects on the breastfed child from Depo-Provera CI or from the underlying maternal condition.
8.3Females and Males of Reproductive Potential Depo-Provera CI 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 Depo-Provera CI [see Warnings and Precautions (5.15) ] .
8.4Pediatric Use Depo-Provera CI is not indicated before menarche. Use of Depo-Provera CI 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 Depo-Provera CI 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 ▾
8.1Pregnancy Risk Summary There is no use for contraception in pregnancy; therefore, Depo-Provera CI 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 ▾
8.4Pediatric Use Depo-Provera CI is not indicated before menarche. Use of Depo-Provera CI 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 Depo-Provera CI 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 ▾
8.5Geriatric Use This product has not been studied in post-menopausal women and is not indicated in this population.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Depo-Provera CI (medroxyprogesterone acetate [MPA]) 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 Depo-Provera CI.
12.3Pharmacokinetics Absorption Following a single 150 mg IM dose of Depo-Provera CI 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). Elimination 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 Depo-Provera CI 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 Depo-Provera CI is unknown.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Depo-Provera CI (medroxyprogesterone acetate [MPA]) 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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Depo-Provera CI is supplied in the following strengths and package configurations: Package Configuration Strength NDC Depo-Provera CI (medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL) 1 mL vial 150 mg/mL NDC 0009-0746-30 25 × 1 mL vials 150 mg/mL NDC 0009-0746-35 Depo-Provera CI prefilled syringes packaged with 22 gauge × 1 1/2 inch Terumo® SurGuard™ Needles 1 mL prefilled syringe 150 mg/mL NDC 0009-7376-11 Vials MUST be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
📦 Storage and Handling ▾
Vials MUST be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
📋 Description ▾
11 DESCRIPTION Depo-Provera CI 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: Depo-Provera CI for IM injection is available in vials and prefilled syringes, each containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL.
For Depo-Provera CI 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 Depo-Provera CI 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 ▾
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 Depo-Provera CI continues, without other therapy being required. • Counsel patients about the possible increased risk of breast cancer in women who use Depo-Provera CI [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 Depo-Provera CI. • Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with Depo-Provera CI.
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com . To contact Pfizer’s Medical Information Department please visit www.pfizermedinfo.com or call 1‑800‑438‑1985.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Following a single 150 mg IM dose of Depo-Provera CI 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). Elimination 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 Depo-Provera CI 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 Depo-Provera CI is unknown.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics No specific pharmacodynamic studies were conducted with Depo-Provera CI.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Contraception In five clinical studies using Depo-Provera CI, the 12-month failure rate for the group of women treated with Depo-Provera CI was zero (no pregnancies reported) to 0.7 by Life-Table method. The effectiveness of Depo‑Provera CI is dependent on the patient returning every 3 months (13 weeks) for reinjection.
14.2Bone Mineral Density Changes in Women Treated with Depo-Provera CI In a controlled, clinical study, adult women using Depo-Provera CI (150mg) 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 Depo-Provera CI, 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 Depo-Provera CI 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 Depo-Provera The treatment group consisted of women who received Depo-Provera CI 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. Depo-Provera Control Depo-Provera 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 Depo-Provera CI The impact of Depo-Provera CI (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 Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI (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 Adolescents Longer duration of treatment and smoking were associated with less recovery of BMD following the last injection of Depo-Provera CI. Table 6 shows the extent of recovery of BMD up to 60 months post… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
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 ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility [see Warnings and Precautions (5.3 , 5.15 ) and Use in Specific Populations (8.3) ] .
📚 References ▾
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 ▾
Patient Information Depo-Provera ® ( DEP-po pro-VAIR-ah ) CI (medroxyprogesterone acetate injectable suspension) Contraceptive Injection Read this Patient Information carefully before you decide if Depo-Provera CI 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 Depo-Provera CI, 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 Depo-Provera CI? Depo-Provera CI can cause serious side effects, including: • Use of Depo-Provera CI may cause you to lose calcium stored in your bone and decrease your bone mass.
The longer you use Depo-Provera CI, the greater your loss of calcium from your bones. Your bones may not recover completely when you stop using Depo-Provera CI. • If you use Depo-Provera CI 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 Depo-Provera CI 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 Depo-Provera CI (see " What are the possible side effects of Depo-Provera CI? ").
Depo-Provera CI is intended to prevent pregnancy. Depo-Provera CI does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs). What is Depo-Provera CI?
Depo-Provera CI is a progestin hormone birth control method that is given by injection (a shot) to prevent pregnancy. How well does Depo-Provera CI work? Your chance of getting pregnant depends on how well you follow the directions for taking your Depo-Provera CI.
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 Depo-Provera CI. 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 Depo-Provera CI? • Depo-Provera CI 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 Depo-Provera CI, 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. • Depo-Provera CI 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 Depo-Provera CI, you should see your healthcare professional every year for a blood pressure check and other healthcare needs.
Who Should Not Use Depo-Provera CI? Do not use Depo-Provera CI if you: • have bleeding from your vagina that has not been explained • have breast cancer now or in the past, or think you have breast cancer • have had a stroke • ever had blood clots in your arms, legs or lungs • have problems with your liver or liver disease • are allergic to med… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Warnings and Precautions, Meningioma ( 5.4 ) 12/2025
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 150 mg/mL Vial Label NDC 0009-0746-30 Rx only Depo-Provera ® Contraceptive Injection medroxy PROGESTER one acetate injectable suspension, USP 150 mg/mL PRINCIPAL DISPLAY PANEL - 150 mg/mL Vial Label
PRINCIPAL DISPLAY PANEL - 150 mg/mL Vial Carton Pfizer NDC 0009-0746-30 Rx only Depo-Provera ® Contraceptive Injection medroxy PROGESTER one acetate injectable suspension, USP 150 mg/mL 1 mL Single-Dose Vial For intramuscular use only PRINCIPAL DISPLAY PANEL - 150 mg/mL Vial Carton
PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label Pfizer NDC 0009-7376-11 Rx only Depo-Provera ® Contraceptive Injection 150 mg per mL medroxyprogesterone acetate injectable suspension, USP Intramuscular use only 1 mL Single Dose Syringe Shake vigorously before use Pfizer Inc, New York, NY 10001 LOT/EXP PAA234178 PRINCIPAL DISPLAY PANEL - 1 mL Syringe Label
PRINCIPAL DISPLAY PANEL - 1 mL Syringe Carton - NDC 0009-7376-11 NDC 0009-7376-11 Pfizer Depo-Provera ® Contraceptive Injection (medroxyprogesterone acetate) injectable suspension, USP 150 mg per mL Intramuscular use only Rx only Single Use Syringe 1 mL Prefilled Syringe PRINCIPAL DISPLAY PANEL - 1 mL Syringe Carton - NDC 0009-7376-11
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