Medroxyprogesterone Acetate
- Product NDC
- 0548-5701
- 11-digit product format
- 005485701
- Labeler code
- 0548
- Product ID
- 0548-5701_fe3eb29d-0024-4834-a1af-81661804f532
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Medroxyprogesterone acetate
- Dosage form
- INJECTION, SUSPENSION, EXTENDED RELEASE
- Route
- INTRAMUSCULAR
- Labeler
- Amphastar Pharmaceuticals, Inc.
- Application
- ANDA077334
- 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
- 2027-12-31
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 |
|---|
| 0548-5701 | MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION, EXTENDED RELEASE [AMPHASTAR PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC | 20211216_fda1aa8a-5739-482a-b4f6-9741ef4d9977.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0548-5701-00 | 00548570100 | 1 SYRINGE in 1 CARTON (0548-5701-00) / 1 mL in 1 SYRINGE | 1 syringe | 2017-11-28 | 0000-00-00 | No | No | Current |