NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
- Product NDC
- 0378-7274
- 11-digit product format
- 003787274
- Labeler code
- 0378
- Product ID
- 0378-7274_8a7faa9f-224f-fb2e-fde2-986d2142dc2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norethindrone acetate and ethinyl estradiol
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA202770
- Marketing category
- ANDA
- Marketing start
- 2019-09-25
- Substance
- ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- .03; 1.5 mg/1; mg/1
- Pharmacologic classes
- Estrogen Receptor Agonists [MoA], Estrogen [EPC], 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 AND ETHINYL ESTRADIOL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ETHINYL ESTRADIOL | .03 mg/1 |
| NORETHINDRONE ACETATE | 1.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 423D2T571U, 9S44LIC7OJ |
| Rxcui | 1359022, 1359028 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-7274-53 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 3 in 1 CARTON | TABLET | 3 | | 6 |
| 0378-7274-85 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 1 in 1 POUCH | TABLET | 1 | | 6 |
| 0378-7274-85 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 21 in 1 BLISTER PACK | TABLET | 21 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-7274 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20250221_3108a9bc-3378-459d-8f6b-bd5eff2ad657.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 |
|---|
| 0378-7274-53 | 00378727453 | 3 POUCH in 1 CARTON (0378-7274-53) / 1 BLISTER PACK in 1 POUCH (0378-7274-85) / 21 TABLET in 1 BLISTER PACK | 3 pouch | 2019-09-25 | 0000-00-00 | No | No | Current |
| 0378-7274-85 | 00378727485 | 1 in 1 POUCH | | | | | | Historical |