Medroxyprogesterone Acetate
- Product NDC
- 0548-5410
- 11-digit product format
- 005485410
- Labeler code
- 0548
- Product ID
- 0548-5410_24f666b3-e168-4860-87d3-bd6c02617ede
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Medroxyprogesterone acetate
- Dosage form
- INJECTION, SUSPENSION, EXTENDED RELEASE
- Route
- INTRAMUSCULAR
- Labeler
- Amphastar Pharmaceuticals, Inc.
- Application
- ANDA077235
- Marketing category
- ANDA
- Marketing start
- 2017-11-28
- Substance
- MEDROXYPROGESTERONE ACETATE
- Active strength
- 150 mg/mL
- Pharmacologic classes
- Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Medroxyprogesterone Acetate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEDROXYPROGESTERONE ACETATE | 150 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C2QI4IOI2G |
| Rxcui | 1000126, 1000153 |
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0548-5410 | MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION, EXTENDED RELEASE [AMPHASTAR PHARMACEUTICALS, INC.] | 2 | Current NDC, Legacy NDC | 20221221_e364a31e-8926-4bda-b00e-efb097bd3830.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0548-5410-00 | 00548541000 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0548-5410-00) / 1 mL in 1 VIAL, SINGLE-DOSE | 2019-05-01 | 0000-00-00 | No | No | Current |
| 0548-5410-25 | 00548541025 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0548-5410-25) / 1 mL in 1 VIAL, SINGLE-DOSE | 2019-05-01 | 0000-00-00 | No | No | Current |