NDC 35916-1592-01 - icosapent ethyl
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
- 35916-1592
- Requested NDC
- 35916-1592-01
- Package NDCs from labels
- 35916-1592-1, 35916-1592-01
- Manufacturer
- Softgel Healthcare Private Limited
- Effective date
- 2026-07-09
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| icosapent ethyl - Softgel Healthcare Private Limited | Softgel Healthcare Private Limited | 2026-07-09 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 35916-1592-1 | icosapent ethyl | 120 in 1 BOTTLE | CAPSULE | 120 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 35916-1592 | ICOSAPENT ETHYL CAPSULE [SOFTGEL HEALTHCARE PRIVATE LIMITED] | 1 | Current NDC, 1 package rows | 20250302_6f5838cd-4d17-401d-8e2a-652d0e73c1e9.zip |
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 |
|---|---|---|---|---|---|---|
| EltaMD UV Restore | TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN | CP Skin Health Group, Inc | 37fee381-ce6b-4949-9a4a-778aa839fb84 | 2026-08-06 | Warnings | 15FIX9V2JP |
| Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEY | OCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8% | Lale Cosmetics LLC | 581fb0cd-c55d-d562-e063-6394a90a7f11 | 2026-08-03 | Warnings | 15FIX9V2JP |
| EltaMD UV Active | ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREEN | CP Skin Health Group, Inc | 39d16479-d491-4c19-aa11-674461687c7b | 2026-08-03 | Warnings | 15FIX9V2JP |
| Continuous Correction Cream | TITANIUM DIOXIDE | Baxter of California, LLC | 1cbcc648-f2e1-af60-e063-6294a90ad4bb | 2026-07-31 | Warnings | 15FIX9V2JP |
| Cover Creme | TITANIUM DIOXIDE | Baxter of California | 31f5e8c4-523f-4596-e063-6294a90a6a12 | 2026-07-31 | Warnings | 15FIX9V2JP |
| Garzulys | INSULIN ASPART-FSAN | Meitheal Pharmaceuticals Inc. | 30c64769-d2f7-4604-ac9e-2a6bc09506c9 | 2026-07-31 | Warnings, Adverse reactions | 059QF0KO0R |
| Icosapent Ethyl | ICOSAPENT ETHYL | Northstar Rx LLC | 45f8bb41-bdb1-4afc-83ec-9dc69720ee9c | 2026-07-29 | Warnings, Adverse reactions | 1304979 6GC8A4PAYH |
| DECONIMO Reconstitution | DECONIMO RECONSTITUTION | Image Amazon LLC | 57ab9b1c-9a18-3786-e063-6394a90a2c63 | 2026-07-28 | Warnings | 059QF0KO0R |
| Topwin Speedy Enema | GLYCERIN | Health Chemical Pharmaceutical Co., Ltd | 3ba8c3d2-1780-42e1-bec5-8f98771d475e | 2026-07-27 | Warnings | PDC6A3C0OX |
| ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-C | OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE | BEL STAR S.A. | 575fb2c3-e332-8a3b-e063-6394a90a9fd9 | 2026-07-24 | Warnings | 15FIX9V2JP |
| Icosapent Ethyl | ICOSAPENT ETHYL | Dr. Reddy's Laboratories, Inc. | cdcee03e-5df1-a8fc-7490-dfdc624ce6d6 | 2026-07-22 | Warnings, Adverse reactions | 1811180 6GC8A4PAYH |
| Icosapent | ICOSAPENT ETHYL | Dr. Reddy's Laboratories, Inc. | 1aca884c-c464-900d-ac06-33aee7118df8 | 2026-07-22 | Warnings, Adverse reactions | 1304979 6GC8A4PAYH |
| True Coast SPF 50 Mineral Sunscreen | ZINC OXIDE 18%, TITANIUM DIOXIDE 6% | Foshan Sugar Max Cosmetics CO.,Ltd | 5379466d-8d14-5fc2-e063-6394a90abd7e | 2026-07-22 | Warnings | 15FIX9V2JP |
| Droptics Dry Eye Relief | CARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80 | Droptics LLC | 29d7614b-f4b7-48e2-97c5-d1bff27731d2 | 2026-07-22 | Warnings | PDC6A3C0OX |
| PNV-Omega | ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENT | Acella Pharmaceuticals, LLC | 735c5531-137f-4cee-8c68-ae121045a8ff | 2026-07-22 | Boxed warning, Warnings, Adverse reactions | H4N855PNZ1 |
| Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation | OCTINOXATE AND TITANIUM DIOXIDE | SICOS ET CIE | 571f23e9-1126-e32d-e063-6294a90a9951 | 2026-07-21 | Warnings | 15FIX9V2JP |
| Sterile Water | WATER | Cardinal Health 107, LLC | 9655cd02-82b5-4a75-813b-854b19551481 | 2026-07-21 | Warnings, Adverse reactions | 059QF0KO0R |
| MENS SPF50 ALL IN ONE SUNSCREEN | MENS SPF50 ALL IN ONE SUNSCREEN | Lance (Guangzhou) Biological Technology Co., Ltd. | 57074480-77fd-cc06-e063-6294a90a28d4 | 2026-07-20 | Warnings | 15FIX9V2JP |
| Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte Foundation | OCTINOXATE AND TITANIUM DIOXIDE | L'Oreal USA Products Inc | 5711364c-f9b4-bfa6-e063-6294a90ace4a | 2026-07-20 | Warnings | 15FIX9V2JP |
| Icosapent Ethyl | ICOSAPENT ETHYL | Hikma Pharmaceuticals USA Inc. | e3d38d1d-fbe7-413d-849a-675e7dfa9b0a | 2026-07-09 | Warnings, Adverse reactions | 1304979 1811180 6GC8A4PAYH |