Medroxyprogesterone
- Product NDC
- 54348-805
- 11-digit product format
- 543480805
- Labeler code
- 54348
- Product ID
- 54348-805_eaa58b56-e846-aab7-e053-2995a90a49c2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MEDROXYPROGESTERONE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PharmPak, Inc.
- Application
- ANDA040159
- Marketing category
- ANDA
- Marketing start
- 2019-07-12
- Substance
- MEDROXYPROGESTERONE ACETATE
- Active strength
- 10 mg/1
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEDROXYPROGESTERONE ACETATE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C2QI4IOI2G |
| Rxcui | 1000114 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54348-805-05 | Medroxyprogesterone | 1 in 1 BOX | TABLET | 1 | | 2 |
| 54348-805-05 | Medroxyprogesterone | 5 in 1 BOTTLE | TABLET | 5 | | 2 |
| 54348-805-10 | Medroxyprogesterone | 1 in 1 BOX | TABLET | 1 | | 2 |
| 54348-805-10 | Medroxyprogesterone | 10 in 1 BOTTLE | TABLET | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54348-805 | MEDROXYPROGESTERONE TABLET [PHARMPAK, INC.] | 2 | Current NDC, Legacy NDC, 4 package rows | 20221011_1403a9a9-c04a-432f-8819-4850f779312e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54348-805-05 | 54348080505 | 1 BOTTLE in 1 BOX (54348-805-05) / 5 TABLET in 1 BOTTLE | 1 bottle | 2019-07-12 | 0000-00-00 | No | No | Current |
| 54348-805-10 | 54348080510 | 1 BOTTLE in 1 BOX (54348-805-10) / 10 TABLET in 1 BOTTLE | 1 bottle | 2019-07-12 | 0000-00-00 | No | No | Current |