Norethindrone
- Product NDC
- 68462-305
- 11-digit product format
- 684620305
- Labeler code
- 68462
- Product ID
- 68462-305_5a1f7007-bfeb-4899-a1a3-b3c005cbcabb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Norethindrone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA091209
- Marketing category
- ANDA
- Marketing start
- 2010-11-03
- 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 |
|---|
| 68462-305-29 | Norethindrone | 3 in 1 CARTON | TABLET | 3 | | 8 |
| 68462-305-84 | Norethindrone | 28 in 1 POUCH | TABLET | 28 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NORETHINDRONE | ACTIVE INGREDIENT | T18F433X4S | NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| NORETHINDRONE | ACTIVE MOIETY | T18F433X4S | NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-305 | NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240104_0d2f8fea-3675-40d2-afd9-9fcb148dbd4b.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 |
|---|
| 68462-305-29 | 68462030529 | 3 POUCH in 1 CARTON (68462-305-29) / 28 TABLET in 1 POUCH (68462-305-84) | 3 pouch | 2010-11-03 | 0000-00-00 | No | No | Current |
| 68462-305-84 | 68462030584 | 28 in 1 POUCH | | | | | | Historical |