NDC 0378-7285-85 - LEVONORGESTREL AND ETHINYL ESTRADIOL 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
- 0378-7285
- Requested NDC
- 0378-7285-85
- Package NDCs from labels
- 0378-7285-85, 0378-7285-90
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Effective date
- 2024-02-15
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| LEVONORGESTREL AND ETHINYL ESTRADIOL - Mylan Pharmaceuticals Inc. | Mylan Pharmaceuticals Inc. | 2024-02-15 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0378-7285-85 | EA - Each | 0378-7285 | 71b51272-cc18-4724-a617-136b030b6d63 | 1 | 2022-06-06 |
| 0378-7285-90 | EA - Each | 0378-7285 | 5a8bbb84-5882-4c96-b33c-3f2ad100108b | 1 | 2015-07-20 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Vitalipid N | VITAMIN A PALMITATE, ERGOCALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, PHYTONADIONE | Fresenius Kabi USA, LLC | 704119cc-d2ad-408a-b213-fe232f7fe2ba | 2023-09-07 | 7QWA1RIO01 | |
| Levonorgestrel | LEVONORGESTREL | Xiromed LLC | 626a2333-ff56-ef28-a287-b33bacc0302a | 2023-09-05 | Warnings | 5W7SIA7YZW |
| LILETTA | LEVONORGESTREL | Allergan, Inc. | aaf0eb2a-f88a-4f26-a445-0fd30176c326 | 2023-06-29 | Warnings, Adverse reactions | 5W7SIA7YZW |
| Levonorgestrel | LEVONORGESTREL | Naari Pte Limited | be8b7ace-9af8-4417-85fa-863e19072887 | 2023-03-16 | Warnings | 5W7SIA7YZW |
| Next Choice One Dose | LEVONORGESTREL | Foundation Consumer Healthcare LLC | 504735bd-6af9-4588-bf85-d09dbf2a7e41 | 2023-02-02 | Warnings | 5W7SIA7YZW |
| Take Action | LEVONORGESTREL | Foundation Consumer Healthcare LLC | 78eee7c9-5ca5-45af-898f-92a2f3b2598e | 2023-01-31 | Warnings | 5W7SIA7YZW |
| Aftera | LEVONORGESTREL | Foundation Consumer Healthcare LLC | 53ad8dff-9134-475c-90b3-8087753e17c4 | 2023-01-31 | Warnings | 5W7SIA7YZW |
| Plan B One-Step | LEVONORGESTREL | Foundation Consumer Healthcare LLC | 6ce6b40e-14ac-47bd-a648-ddf9e452e559 | 2023-01-31 | Warnings | 5W7SIA7YZW |
| Opcicon One-Step | LEVONORGESTREL | Sun Pharmaceutical Industries, Inc. | b67ca313-561e-471f-baf3-257b7e253c75 | 2023-01-13 | Warnings | 5W7SIA7YZW |
| Morning After | LEVONORGESTREL | Rapha Pharmaceuticals, Inc. | f0fab784-3d28-35fb-e053-2995a90ab611 | 2022-12-29 | Warnings | 5W7SIA7YZW |
| 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 |
| Optionelle | LEVONORGESTREL TABLET, 1.5 MG | Strides Pharma Inc | 1c7e849c-6392-48a6-9214-907325a012e2 | 2022-09-16 | Warnings | 5W7SIA7YZW |
| Levonorgestrel Tablet, 1.5 mg | LEVONORGESTREL TABLET, 1.5 MG | Strides Pharma Inc | 98f6367e-14d2-4c7a-9418-d996f0040d22 | 2022-09-13 | Warnings | 5W7SIA7YZW |
| My Choice TM | LEVONORGESTREL | Proficient Rx LP | 165f7270-d050-4e97-b30f-107b96940d84 | 2022-09-01 | Warnings | 5W7SIA7YZW |
| ZAFEMY | NORELGESTROMIN AND ETHINYL ESTRADIOL | Amneal Pharmaceuticals LLC | 5ee34c07-65af-42b8-a98f-e299ff90a8a1 | 2022-04-30 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| My Choice TM | LEVONORGESTREL | SUN PHARMACEUTICAL INDUSTRIES, INC. | 66753300-fb61-4f09-af74-ee498b0bd595 | 2022-04-21 | Warnings | 5W7SIA7YZW |
| 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 5W7SIA7YZW |
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.