NORETHINDRONE
- Product NDC
- 0378-7292
- 11-digit product format
- 003787292
- Labeler code
- 0378
- Product ID
- 0378-7292_952f8023-4a5f-746d-c678-388b50e8909c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norethindrone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA201483
- Marketing category
- ANDA
- Marketing start
- 2013-07-12
- Substance
- NORETHINDRONE
- Active strength
- .35 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NORETHINDRONE | .35 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | T18F433X4S |
| Rxcui | 198042, 748961 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-7292-53 | NORETHINDRONE | 3 in 1 CARTON | TABLET | 3 | | 8 |
| 0378-7292-85 | NORETHINDRONE | 1 in 1 POUCH | TABLET | 1 | | 8 |
| 0378-7292-85 | NORETHINDRONE | 28 in 1 BLISTER PACK | TABLET | 28 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-7292 | NORETHINDRONE TABLET [MYLAN PHARMACEUTICALS INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20250221_af851d82-b30f-463b-9dba-0437225dc1ee.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 |
|---|
| 0378-7292-53 | 00378729253 | 3 POUCH in 1 CARTON (0378-7292-53) / 1 BLISTER PACK in 1 POUCH (0378-7292-85) / 28 TABLET in 1 BLISTER PACK | 3 pouch | 2013-07-12 | 0000-00-00 | No | No | Current |
| 0378-7292-85 | 00378729285 | 1 in 1 POUCH | | | | | | Historical |