Norethindrone
- Product NDC
- 60505-4900
- 11-digit product format
- 605054900
- Labeler code
- 60505
- Product ID
- 60505-4900_4b7b2bbf-275b-463a-e063-6294a90a59d2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Apotex Corp.
- Application
- ANDA206807
- Marketing category
- ANDA
- Marketing start
- 2026-03-24
- Substance
- NORETHINDRONE
- Active strength
- .35 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
- Listing expiration
- 2027-12-31
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 |
|---|
| 60505-4900-8 | Norethindrone | 3 in 1 CARTON | TABLET | 3 | | 1 |
| 60505-4900-8 | Norethindrone | 28 in 1 BLISTER PACK | TABLET | 28 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 60505-4900-8 | 60505490008 | 3 BLISTER PACK in 1 CARTON (60505-4900-8) / 28 TABLET in 1 BLISTER PACK | 3 blister pack | 2026-03-24 | No | No | Current |