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
DailyMed Product Concepts#
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-7283-53 | EA - Each | 0378-7283 | 3dedd15c-ec75-4d6a-8619-ea4c83c23820 | 1 | 2014-08-01 |
| 0378-7283-85 | EA - Each | 0378-7283 | 5440c685-4f4f-4695-ac3e-52d136e35257 | 1 | 2021-05-05 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1358763 | {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack | GPCK | 2376cab5-3d34-4a0a-9ba1-df19a96eb5dd | 12 |
| 1358763 | Eth-estra-Noreth Ac 0.02-1 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack | PSN | 2376cab5-3d34-4a0a-9ba1-df19a96eb5dd | 12 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | PSN | 2376cab5-3d34-4a0a-9ba1-df19a96eb5dd | 12 |
| 1358762 | norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 2376cab5-3d34-4a0a-9ba1-df19a96eb5dd | 12 |
| 1358762 | ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet | SCD | 2376cab5-3d34-4a0a-9ba1-df19a96eb5dd | 12 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | SCD | 2376cab5-3d34-4a0a-9ba1-df19a96eb5dd | 12 |
| 1358762 | ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Tablet | SY | 2376cab5-3d34-4a0a-9ba1-df19a96eb5dd | 12 |
| 1358763 | {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack | GPCK | 8270e9cd-7bc5-4706-beb0-cb861f802f09 | 1 |
| 1358763 | Eth-estra-Noreth Ac 0.02-1 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 28 Day Pack | PSN | 8270e9cd-7bc5-4706-beb0-cb861f802f09 | 1 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | PSN | 8270e9cd-7bc5-4706-beb0-cb861f802f09 | 1 |
| 1358762 | norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral Tablet | PSN | 8270e9cd-7bc5-4706-beb0-cb861f802f09 | 1 |
| 1358762 | ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet | SCD | 8270e9cd-7bc5-4706-beb0-cb861f802f09 | 1 |
| 259176 | ferrous fumarate 75 MG Oral Tablet | SCD | 8270e9cd-7bc5-4706-beb0-cb861f802f09 | 1 |
| 1358762 | ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Tablet | SY | 8270e9cd-7bc5-4706-beb0-cb861f802f09 | 1 |
Packages#
| 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 |