Norethindrone Acetate
- Product NDC
- 65162-475
- 11-digit product format
- 651620475
- Labeler code
- 65162
- Product ID
- 65162-475_764f6075-288a-4435-b148-35589e5e5835
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA200275
- Marketing category
- ANDA
- Marketing start
- 2009-07-01
- 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 |
|---|
| 65162-475-03 | Norethindrone Acetate | 30 in 1 BOTTLE | TABLET | 30 | | 18 |
| 65162-475-05 | Norethindrone Acetate | 50 in 1 BOTTLE | TABLET | 50 | | 18 |
| 65162-475-09 | Norethindrone Acetate | 90 in 1 BOTTLE | TABLET | 90 | | 18 |
| 65162-475-50 | Norethindrone Acetate | 500 in 1 BOTTLE | TABLET | 500 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NORETHINDRONE ACETATE | ACTIVE INGREDIENT | 9S44LIC7OJ | NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| NORETHINDRONE | ACTIVE MOIETY | T18F433X4S | NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| LACTOSE, UNSPECIFIED FORM | INACTIVE INGREDIENT | J2B2A4N98G | NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 12 | |
| NORETHINDRONE ACETATE | ACTIVE INGREDIENT | 9S44LIC7OJ | NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AVKARE, INC.] | 1 | |
| NORETHINDRONE | ACTIVE MOIETY | T18F433X4S | NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AVKARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AVKARE, INC.] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AVKARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AVKARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-475 | NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AMNEAL PHARMACEUTICALS LLC] | 18 | Current NDC, Legacy NDC, 4 package rows | 20241031_64cb920c-36e8-4d62-9d08-3ddf3989d313.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 |
|---|
| 65162-475-03 | 65162047503 | 30 TABLET in 1 BOTTLE (65162-475-03) | 30 tablet | 2009-07-01 | 0000-00-00 | No | No | Current |
| 65162-475-05 | 65162047505 | 50 TABLET in 1 BOTTLE (65162-475-05) | 50 tablet | 2009-07-01 | 0000-00-00 | No | No | Current |
| 65162-475-09 | 65162047509 | 90 TABLET in 1 BOTTLE (65162-475-09) | 90 tablet | 2009-07-01 | 0000-00-00 | No | No | Current |
| 65162-475-50 | 65162047550 | 500 TABLET in 1 BOTTLE (65162-475-50) | 500 tablet | 2009-07-01 | 0000-00-00 | No | No | Current |