NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
- Product NDC
- 0378-7303
- 11-digit product format
- 003787303
- Labeler code
- 0378
- Product ID
- 0378-7303_931f0bbe-68fa-5010-6d73-7f97e3d9eddf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norethindrone acetate and ethinyl estradiol and ferrous fumarate
- Dosage form
- KIT
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA205069
- Marketing category
- ANDA
- Marketing start
- 2022-07-27
- 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 AND FERROUS FUMARATE
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 259176, 1358762, 1359130, 1359131, 1359132 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-7190-98 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 5 in 1 BLISTER PACK | TABLET | 5 | 20 ug | 4 |
| 0378-7191-71 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 7 in 1 BLISTER PACK | TABLET | 7 | 30 ug | 4 |
| 0378-7192-59 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 9 in 1 BLISTER PACK | TABLET | 9 | 35 ug | 4 |
| 0378-7303-53 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 3 in 1 CARTON | KIT | 3 | | 4 |
| 0378-7303-85 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 1 in 1 POUCH | KIT | 1 | | 4 |
| 0378-7303-85 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | 1 in 1 BLISTER PACK | KIT | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-7303 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE KIT [MYLAN PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 6 package rows | 20250221_054917fa-573b-4b16-a719-ece6c0909656.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 |
|---|
| 0378-7190-98 | 00378719098 | 5 in 1 BLISTER PACK | | | | | | Historical |
| 0378-7191-71 | 00378719171 | 7 in 1 BLISTER PACK | | | | | | Historical |
| 0378-7192-59 | 00378719259 | 9 in 1 BLISTER PACK | | | | | | Historical |
| 0378-7303-53 | 00378730353 | 3 POUCH in 1 CARTON (0378-7303-53) / 1 BLISTER PACK in 1 POUCH (0378-7303-85) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (0378-7191-71) * 9 TABLET in 1 BLISTER PACK (0378-7192-59) * 7 TABLET in 1 BLISTER PACK (0378-7193-71) * 5 TABLET in 1 BLISTER PACK (0378-7190-98) | 3 pouch | 2022-07-27 | 0000-00-00 | No | No | Current |
| 0378-7303-85 | 00378730385 | 1 in 1 POUCH | | | | | | Historical |