MEDROXYPROGESTERONE ACETATE
- Product NDC
- 55150-329
- 11-digit product format
- 551500329
- Labeler code
- 55150
- Product ID
- 55150-329_2db6b7cc-c245-4ea2-a117-ff231d6c5b95
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MEDROXYPROGESTERONE ACETATE
- Dosage form
- INJECTION, SUSPENSION
- Route
- INTRAMUSCULAR
- Labeler
- Eugia US LLC
- Application
- ANDA212824
- Marketing category
- ANDA
- Marketing start
- 2022-08-22
- Substance
- MEDROXYPROGESTERONE ACETATE
- Active strength
- 150 mg/mL
- Pharmacologic classes
- Progesterone Congeners [CS], Progestin [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-329-01 | MEDROXYPROGESTERONE ACETATE | 1 in 1 CARTON | INJECTION, SUSPENSION | 1 | | 4 |
| 55150-329-01 | MEDROXYPROGESTERONE ACETATE | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 1 | | 4 |
| 55150-329-25 | MEDROXYPROGESTERONE ACETATE | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SUSPENSION | 1 | | 4 |
| 55150-329-25 | MEDROXYPROGESTERONE ACETATE | 25 in 1 CARTON | INJECTION, SUSPENSION | 25 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-329 | MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION [EUGIA US LLC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20250121_0655670a-d127-4e08-8a23-ace64b2503b2.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 |
|---|
| 55150-329-01 | 55150032901 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-329-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2022-08-22 | 0000-00-00 | No | No | Current |
| 55150-329-25 | 55150032925 | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-329-25) / 1 mL in 1 VIAL, SINGLE-DOSE | 2022-08-22 | 0000-00-00 | No | No | Current |