Norethindrone Acetate
- Product NDC
- 42291-650
- 11-digit product format
- 422910650
- Labeler code
- 42291
- Product ID
- 42291-650_3f07bf1f-a9bc-c5ad-e063-6394a90a7545
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA200275
- Marketing category
- ANDA
- Marketing start
- 2013-06-18
- Substance
- NORETHINDRONE ACETATE
- Active strength
- 5 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
- Norethindrone Acetate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NORETHINDRONE ACETATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9S44LIC7OJ |
| Rxcui | 1000405 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-650-90 | Norethindrone Acetate | 90 in 1 BOTTLE | TABLET | 90 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-650 | NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AVKARE] | 9 | Current NDC, Legacy NDC, 1 package rows | 20240111_827c7ef1-a8b7-d0c4-b062-c5154b331a35.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 |
|---|
| 42291-650-90 | 42291065090 | 90 TABLET in 1 BOTTLE (42291-650-90) | 90 tablet | 2013-06-18 | 0000-00-00 | No | No | Current |