NDC 0378-7286-85 - NORGESTIMATE AND ETHINYL ESTRADIOL
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
- 0378-7286
- Requested NDC
- 0378-7286-85
- Package NDCs from labels
- 0378-7286-85, 0378-7286-53
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Effective date
- 2017-09-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| NORGESTIMATE AND ETHINYL ESTRADIOL - Mylan Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. | 2017-09-28 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-7286-53 | EA - Each | 0378-7286 | 570ed40a-882e-4561-87ef-c09c5614acb4 | 1 | 2019-02-13 |
| 0378-7286-85 | EA - Each | 0378-7286 | bdc9fb6c-b098-45a3-abd0-34f145b93a78 | 1 | 2019-02-13 |
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 |
|---|---|---|---|---|---|---|
| Anubis Barcelona | GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE | ANUBIS COSMETICS SL | eb651769-4d98-2b3b-e053-2a95a90a36b0 | 2023-09-01 | Warnings | H3R47K3TBD |
| Anubis Barcelona Total Hydrating | BETAINE, GLYCERIN, POLYSORBATE 20 | ANUBIS COSMETICS SL | eaefe3b9-9064-18b1-e053-2a95a90a5765 | 2023-09-01 | Warnings | H3R47K3TBD |
| Anubis Barcelona New Even | LACTIC ACID, CITRIC ACID, GLYCOLIC ACID | ANUBIS COSMETICS SL | eaeeb6e0-5322-20c4-e053-2995a90a9fd9 | 2023-09-01 | Warnings | H3R47K3TBD |
| Etonogestrel and Ethinyl Estradiol | ETONOGESTREL AND ETHINYL ESTRADIOL | Teva Pharmaceuticals USA, Inc. | a8cc104a-d522-49ad-af54-2f312b829b61 | 2022-09-30 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| ZAFEMY | NORELGESTROMIN AND ETHINYL ESTRADIOL | Amneal Pharmaceuticals LLC | 5ee34c07-65af-42b8-a98f-e299ff90a8a1 | 2022-04-30 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| Norelgestromin and Ethinly Estradiol | NORELGESTROMIN AND ETHINLY ESTRADIOL | Amneal Pharmaceuticals NY LLC | 36445b6a-e0f2-42f7-a8f3-5b80c90b87dd | 2022-03-30 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| XULANE | NORELGESTROMIN AND ETHINYL ESTRADIOL | Mylan Pharmaceuticals Inc. | f7848550-086a-43d8-8ae5-047f4b9e4382 | 2022-03-04 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| Amethyst | LEVONORGESTREL AND ETHINYL ESTRADIOL | Teva Pharmaceuticals, Inc. | 99073fe0-eac8-44dd-abe6-623fa67d9e79 | 2022-01-31 | Warnings, Adverse reactions | 423D2T571U |
| Nortrel 28 Day | NORETHINDRONE AND ETHINYL ESTRADIOL | Teva Pharmaceuticals USA, Inc. | 140c50d6-c931-423a-9aa0-526eae7ab93c | 2021-12-01 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| 0a3f7279-ec55-4c42-a528-dde9749f68fd | bb2f3b56-6976-46e1-9a52-2db8756f22dc | 2017-09-28 | Boxed warning, Warnings, Adverse reactions | bb2f3b56-6976-46e1-9a52-2db8756f22dc |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.