NDC 0378-7294-85 - ESTRADIOL AND NORETHINDRONE ACETATE
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0378-7294
- Requested NDC
- 0378-7294-85
- Package NDCs from labels
- 0378-7294-85, 0378-7294-53
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Effective date
- 2024-04-15
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| ESTRADIOL AND NORETHINDRONE ACETATE - Mylan Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. | 2024-04-15 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-7294-53 | EA - Each | 0378-7294 | 3fc85cb2-7931-4f70-8105-0fd53c2da34a | 1 | 2018-08-13 |
| 0378-7294-85 | EA - Each | 0378-7294 | 37ea8218-4635-4242-85a5-d59e21cfdc56 | 1 | 2018-08-13 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 6ed612c8-c4a7-45d8-b1ed-124042b9e690 | 6cafe148-bfb8-4c09-a056-b0637c0c3065 | 2024-04-15 | Boxed warning, Warnings, Adverse reactions | 6ed612c8-c4a7-45d8-b1ed-124042b9e690 6cafe148-bfb8-4c09-a056-b0637c0c3065 | ||
| Estradiol | ESTRADIOL | Noven Therapeutics, LLC | bf185599-2138-4083-9c52-2b95dce09ae0 | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 80d6644a-d6f2-48e7-a685-92c4255b19fe | 2024-04-05 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | Bryant Ranch Prepack | 414b846a-d6d9-4e8a-9632-12e296fc13c3 | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| YUVAFEM | ESTRADIOL | Amneal Pharmaceuticals LLC | 30c7f6ba-7a9e-4853-b3e4-e00a46560224 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | Amneal Pharmaceuticals of New York LLC | 094830ee-1b1c-4cf7-8a39-427dfd56f9c9 | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | Teva Pharmaceuticals USA, Inc. | 8cb31c7c-fba8-4201-833d-844ea1a8a4de | 2024-04-01 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Pure Cornstarch Baby | CORN STARCH | Walgreen Company | d0e9bd13-b568-4f7e-b036-8d23e71ad8bf | 2024-03-25 | Warnings | O8232NY3SJ |
| Dr Dale Wellness NU Fem 1 2 3 All In One Topical Homeopathic | DHEA,ADRENAL CORTISOL,GLANDULA SUPRARENALIS SUIS,HUMAN GROWTH HORMONE,IGF-I,IGF-II ,HYPOTHALAMUS,PITUITARY,PLACENTA,LIVER,THYMUS,RNA,DNA,ESTROGENIUM,ESTRADIOLINUM,SANGUINARA CANDENSIS,OOPHORINUM,PROGESTERONIUM,PITITUARINUM,PINEAL,FOLLICULINUM,OVARINUM,CHELADONIUM,SULPHUR,SEPIA,LAGENINE ,TESTOSTERONE,CIMICIFUGA BLACK COHOSH,LILIUM TIGRINUM,GRAPHITES,KALI PHOSPHORICUM ,CAUSTICUM,CALCAREA CARBONICA,PHYTOLACCA,SCROPHULARIA NODOSA | DMD Clinical Naturopathy | 7679472c-bc6a-40c1-8e66-adc0b6ca18b4 | 2024-03-21 | Warnings | 4TI98Z838E |
| estradiol | ESTRADIOL | Zydus Pharmaceuticals USA Inc. | 684850eb-d889-4370-a0a7-4a5c3113266a | 2024-03-20 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| estradiol | ESTRADIOL | Zydus Pharmaceuticals USA Inc. | db4696da-7820-4b2b-97b4-fb05b1208020 | 2024-03-20 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| Estradiol | ESTRADIOL | Zydus Pharmaceuticals USA Inc. | 839fe7ae-6835-4d6a-b6b1-ca7f062caa4f | 2024-03-15 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| High Vitality | AGNUS CASTUS, AMBRA GRISEA, PETROSELINUM SATIVUM, ESTRADIOL, L-DOPA, MELATONIN, TESTOSTERONE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GABA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), APIOLUM, | Deseret Biologicals, Inc. | 2fd79cc1-42ed-49f5-b9e1-c48dedd21b1c | 2024-03-13 | Warnings | 4TI98Z838E |
| Etyqa | ESTRADIOL AND NORETHINDRONE ACETATE | Aurobindo Pharma Limited | afbc2a33-5eb2-4f01-91e9-07d8050da6ce | 2024-03-01 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E 9S44LIC7OJ |
| Jinteli | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Teva Pharmaceuticals USA, Inc. | d667ca75-1a17-43fc-9077-f25ce0908f8d | 2024-02-27 | Boxed warning, Warnings, Adverse reactions | 9S44LIC7OJ |
| CombiPatch (estradiol/norethindrone acetate transdermal system) | ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM | Noven Therapeutics, LLC | 83198ef1-11c4-11e4-9191-0800200c9a66 | 2024-02-21 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E 9S44LIC7OJ |
| Estradiol / Norethindrone Acetate | ESTRADIOL AND NORETHINDRONE ACETATE | Breckenridge Pharmaceutical, Inc. | 44125b2f-10ac-435c-bdb4-a29bf8450dbf | 2024-02-21 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E 9S44LIC7OJ |
| Estradiol | ESTRADIOL | Teva Pharmaceuticals USA, Inc. | c4936878-1643-4e7f-9b0d-e4957935aef2 | 2024-02-01 | Boxed warning, Warnings, Adverse reactions | 4TI98Z838E |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Mylan Pharmaceuticals Inc. | 3108a9bc-3378-459d-8f6b-bd5eff2ad657 | 2024-01-15 | Boxed warning, Warnings, Adverse reactions | 9S44LIC7OJ |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Mylan Pharmaceuticals Inc. | 89948751-bd6e-4e9c-b87c-8782706c1097 | 2024-01-15 | Boxed warning, Warnings, Adverse reactions | 9S44LIC7OJ |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.