NDC 51862-028-01 - Lutera
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
- 51862-028
- Requested NDC
- 51862-028-01
- Package NDCs from labels
- 51862-028-01, 51862-028-06
- Manufacturer
- Mayne Pharma Inc. | Patheon, Inc.
- Effective date
- 2025-07-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Lutera® (Levonorgestrel and Ethinyl Estradiol Tablets USP) | Mayne Pharma Inc. | Patheon, Inc. | 2025-07-28 | HUMAN PRESCRIPTION DRUG LABEL |
| Lutera® (Levonorgestrel and Ethinyl Estradiol Tablets USP) | RPK Pharmaceuticals, Inc. | 2020-12-15 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51862-028-01 | Lutera | 1 in 1 BLISTER PACK | KIT | 1 | 7 | |
| 51862-028-06 | Lutera | 6 in 1 CARTON | KIT | 6 | 7 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51862-028-01 | EA - Each | 51862-028 | 93fd91c7-fa83-4307-a955-47d7b5b9a8b2 | 1 | 2016-10-06 |
| 51862-028-06 | EA - Each | 51862-028 | 16806c94-b9e7-494e-adb0-f889c569e653 | 1 | 2016-10-06 |
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 |
|---|---|---|---|---|---|---|
| Best Choice Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | Best Choice | f5ba63f3-7966-81fe-e053-2995a90a342c | 2025-12-30 | Warnings | FZ989GH94E |
| Publix Advanced Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Publix Super Markets, Inc. | f7b0c3d6-0324-46c3-e053-6394a90a8241 | 2025-12-30 | Warnings | FZ989GH94E |
| Kroger Eye Drops Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | The Kroger Company | f76f08c5-0111-8bc5-e053-6294a90a16ee | 2025-12-30 | Warnings | FZ989GH94E |
| Core Values Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Liberty Procurement Co., Inc. | f76dfeca-4e86-0b5d-e053-6294a90a29b9 | 2025-12-30 | Warnings | FZ989GH94E |
| Best Choice Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Valu Merchandisers, Co. | f7491a17-8035-5a3c-e053-6294a90a615c | 2025-12-30 | Warnings | FZ989GH94E |
| Winco Advanced Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | WinCo Foods, LLC | f10778c8-14fe-4852-8b73-42db502fd2bc | 2025-12-30 | Warnings | FZ989GH94E |
| Harris Teeter Eye Drops Advanced Relief | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDE | Harris Teeter, LLC | f76e2831-5c6c-7a62-e053-6294a90a937b | 2025-12-30 | Warnings | FZ989GH94E |
| CareOne Artificial Tears Eye Drops 15mL | POLYVINYL ALCOHOL, POVIDONE | Retail Business Services, LLC | 92fded6b-91fd-d82e-e053-2a95a90ab523 | 2025-12-30 | Warnings | FZ989GH94E |
| Quality Choice Artificial Tears Lubricant Eye Drops | POLYVINYL ALCOHOL, POVIDONE | Chain Drug Marketing Association, Inc. | 1f669655-4bc7-0175-e063-6294a90a305a | 2025-12-30 | Warnings | FZ989GH94E |
| Equate Artificial Tears | POLYVINYL ALCOHOL, POVIDONE | Walmart, Inc. | ead9f271-0f15-1fff-e053-2a95a90a93ac | 2025-12-30 | Warnings | FZ989GH94E |
| Eye Love Heyedrate Long Lasting Hydration | GLYCERIN, POVIDONE | Physician Recommended Neutraceuticals, L.P. | f321dea1-3251-eaa8-e053-2995a90aaf95 | 2025-12-30 | Warnings | FZ989GH94E |
| Quality Choice Moisturizing Relief Eye Drops | DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL | Chain Drug Marketing Association, Inc. | 1fb81759-5931-59c8-e063-6294a90a2277 | 2025-12-30 | Warnings | FZ989GH94E |
| drospirenone and ethinyl estradiol | DROSPIRENONE AND ETHINYL ESTRADIOL | Glenmark Pharmaceuticals Inc., USA | 6d85f252-307c-4aa8-9572-1e74c9819283 | 2025-12-12 | Boxed warning, Warnings, Adverse reactions | 748797 |
| ENSKYCE | DESOGESTREL AND ETHINYL ESTRADIOL | Lupin Pharmaceuticals, Inc. | 799fa1d8-4e7b-4b5e-844d-d638896a4b02 | 2025-12-12 | Boxed warning, Warnings, Adverse reactions | 748797 |
| Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol | LEVONORGESTREL AND ETHINYL ESTRADIOL | Lupin Pharmaceuticals, Inc. | 7d82aa5d-aee9-4c72-9b9b-af7adad21f4c | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | 242297 |
| Norgestimate and ethinyl estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | Lupin Pharmaceuticals, Inc. | 6e8bec6f-17ba-4b37-ae6c-07657815f248 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | 748797 |
| TRI-LO-MARZIA | NORGESTIMATE AND ETHINYL ESTRADIOL | Lupin Pharmaceuticals, Inc. | bc402baa-5de4-4149-9857-081a9b4eb280 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | 748797 |
| Norgestimate and Ethinyl Estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | Lupin Pharmaceuticals, Inc. | c25cd86c-2940-475a-9628-ee75b0294e8d | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | 748797 |
| Levonorgestrel and Ethinyl Estradiol | LEVONORGESTREL AND ETHINYL ESTRADIOL | Lupin Pharmaceuticals, Inc. | 6e686b50-8d36-4a13-91a8-d4ad21cdb735 | 2025-12-09 | Boxed warning, Warnings, Adverse reactions | 748797 242297 748868 |
| Nikki | DROSPIRENONE AND ETHINYL ESTRADIOL | Lupin Pharmaceuticals, Inc. | 9aff6034-044c-466d-bf52-18a998d47f66 | 2025-12-08 | Boxed warning, Warnings, Adverse reactions | 748797 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.