NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
- Product NDC
- 0378-7283
- 11-digit product format
- 003787283
- Labeler code
- 0378
- Product ID
- 0378-7283_024ab85d-682d-b3cb-9886-57dd821426c8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norethindrone acetate and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA202772
- Marketing category
- ANDA
- Marketing start
- 2014-07-16
- 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
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 259176, 1358762, 1358763 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-7283-53 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 3 in 1 CARTON | KIT | 3 | | 12 |
| 0378-7283-85 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 1 in 1 POUCH | KIT | 1 | | 12 |
| 0378-7283-85 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | 1 in 1 BLISTER PACK | KIT | 1 | | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-7283 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL KIT [MYLAN PHARMACEUTICALS INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20250221_2376cab5-3d34-4a0a-9ba1-df19a96eb5dd.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 |
|---|
| 0378-7283-53 | 00378728353 | 3 POUCH in 1 CARTON (0378-7283-53) / 1 BLISTER PACK in 1 POUCH (0378-7283-85) / 1 KIT in 1 BLISTER PACK | 3 pouch | 2014-07-16 | 0000-00-00 | No | No | Current |
| 0378-7283-85 | 00378728385 | 1 in 1 POUCH | | | | | | Historical |