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 |
|---|---|---|---|---|---|---|
| Levonorgestrel | LEVONORGESTREL | Thirty Madison Inc. | 6933ae19-4c8f-49a2-96c5-9cdf37ee5824 | 2024-12-30 | Warnings | 5W7SIA7YZW |
| Junel 21 Day | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Proficient Rx LP | 56e91ad4-f31b-494d-9e75-6dd4f396779c | 2024-12-01 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| JAIMIESS | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL TABLETS | Xiromed LLC | c094e6de-f1e9-9594-43f3-de1c1bb49bdb | 2024-11-25 | Boxed warning, Warnings, Adverse reactions | ANDA200492 |
| Levonorgestrel | LEVONORGESTREL | Ohm Laboratories Inc. | 5c509934-8c11-4d7f-8506-5971c37cfc22 | 2024-09-06 | Warnings | 5W7SIA7YZW |
| Etonogestrel and Ethinyl Estradiol Vaginal Ring | ETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL RING | Northstar Rx LLC | 1488f5ae-3b34-fcd7-6049-215929b1d324 | 2024-06-24 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| EnilloRing | ETONOGESTREL AND ETHINYL ESTRADIOL VAGINAL | Xiromed, LLC | 85a126f6-d3e0-9e12-73f9-6176ba36f58b | 2024-06-24 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| My Way | LEVONORGESTREL | NuCare Pharmaceuticals,Inc. | 6598a875-8be8-0928-e053-2a91aa0a064d | 2024-06-06 | Warnings | 5W7SIA7YZW |
| NUVARING | ETONOGESTREL AND ETHINYL ESTRADIOL | A-S Medication Solutions | e14bc197-dd22-4e6e-8aa1-d6cf2242fe0f | 2024-03-10 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| Jinteli | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Teva Pharmaceuticals USA, Inc. | d667ca75-1a17-43fc-9077-f25ce0908f8d | 2024-02-27 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| XULANE | NORELGESTROMIN AND ETHINYL ESTRADIOL | A-S Medication Solutions | adcf17ef-e60b-48a4-9478-3998dab2bbbd | 2024-02-27 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| f1999ddb-c549-592e-e08e-69865be1d6a4 | e5eb2533-cc31-43a8-8fca-d46d72a59530 | 2024-02-15 | Boxed warning, Warnings, Adverse reactions | f1999ddb-c549-592e-e08e-69865be1d6a4 e5eb2533-cc31-43a8-8fca-d46d72a59530 | ||
| 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 | 423D2T571U |
| 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 | 423D2T571U |
| Quflora Pediatric | VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, DL-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, FOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, AND SODIUM FLUORIDE | CarWin Pharmaceutical Associates, LLC | b8e08798-d8bb-4616-996b-a2c07a5d730a | 2024-01-10 | Warnings, Adverse reactions | 7QWA1RIO01 |
| ZAFEMY | NORELGESTROMIN AND ETHINYL ESTRADIOL | Bryant Ranch Prepack | 77230a20-4269-4abf-ae2a-ac5ccafef565 | 2024-01-05 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| Etonogestrel/Ethinyl Estradiol | ETONOGESTREL AND ETHINYL ESTRADIOL | A-S Medication Solutions | fcf9da2a-bb91-4697-bfaa-c9d58855e275 | 2023-11-22 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| Aurovela 1.5/30 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Aurobindo Pharma Limited | b146e49c-a0fc-4f3d-9ad6-99e8257fa139 | 2023-11-21 | Boxed warning, Warnings, Adverse reactions | 423D2T571U |
| PostDay One-Step | LEVONORGESTREL | Rapha Pharmaceuticals, Inc. | 6f7f5697-acb6-ea95-e053-2991aa0ae7c7 | 2023-11-21 | Warnings | 5W7SIA7YZW |
| Aurovela 1/20 | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | Aurobindo Pharma Limited | 6765becf-7b51-4f33-ac13-70fcd01decf7 | 2023-11-21 | Warnings, Adverse reactions | 423D2T571U |
| Plan B One-Step | LEVONORGESTREL | A-S Medication Solutions | fcc7ba8e-ad54-4efe-87e4-5eb0fbf4f064 | 2023-10-24 | Warnings | 5W7SIA7YZW |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.