Norethindrone Acetate
- Product NDC
- 68462-304
- 11-digit product format
- 684620304
- Labeler code
- 68462
- Product ID
- 68462-304_61f08f82-c9ec-45cf-ab8b-18afabde75e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone Acetate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA091090
- Marketing category
- ANDA
- Marketing start
- 2010-07-21
- Substance
- NORETHINDRONE ACETATE
- Active strength
- 5 mg/1
- 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
- Norethindrone Acetate
- Listing expiration
- 2027-12-31
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 |
|---|
| 68462-304-05 | Norethindrone Acetate | 500 in 1 BOTTLE | TABLET | 500 | | 10 |
| 68462-304-50 | Norethindrone Acetate | 50 in 1 BOTTLE | TABLET | 50 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-304 | NORETHINDRONE ACETATE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240104_d0a94321-eb60-4aa6-a429-f0156f9f8e01.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 |
|---|
| 68462-304-05 | 68462030405 | 500 TABLET in 1 BOTTLE (68462-304-05) | 500 tablet | 2010-07-21 | 0000-00-00 | No | No | Current |
| 68462-304-50 | 68462030450 | 50 TABLET in 1 BOTTLE (68462-304-50) | 50 tablet | 2010-07-21 | 0000-00-00 | No | No | Current |