NDC 0904-7253-35 - Dabigatran Etexilate
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
- 0904-7253
- Requested NDC
- 0904-7253-35
- Package NDCs from labels
- 0904-7253-35, 0904-7253-04, 0904-7253-68
- Manufacturer
- Major Pharmaceuticals | Alkem Laboratories Limited
- Effective date
- 2025-06-12
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Dabigatran Etexilate - Major Pharmaceuticals | Alkem Laboratories Limited | Major Pharmaceuticals | Alkem Laboratories Limited | 2025-06-12 | Human Prescription Drug Label |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-7253-04 | Dabigatran Etexilate | 3 in 1 CARTON | CAPSULE, COATED PELLETS | 3 | 2 | |
| 0904-7253-35 | Dabigatran Etexilate | 10 in 1 BLISTER PACK | CAPSULE, COATED PELLETS | 10 | 2 | |
| 0904-7253-68 | Dabigatran Etexilate | 6 in 1 CARTON | CAPSULE, COATED PELLETS | 6 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7253-04 | EA - Each | 0904-7253 | b5410e85-ccc2-4a3b-add3-7ae457359e35 | 1 | 2025-05-14 |
| 0904-7253-35 | EA - Each | 0904-7253 | e9fe4203-0a1f-4844-9a60-5fe2c007f40d | 1 | 2025-05-14 |
| 0904-7253-68 | EA - Each | 0904-7253 | b8e42253-9fcb-4b5e-872e-6258a83d9eca | 1 | 2025-05-14 |
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 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 |
| IDkit HP ONE | CITRIC ACID ANHYDROUS AND 13C UREA | Meridian Bioscience Israel Ltd | 8baab7a7-5d20-46ad-9c4a-762992ef6b51 | 2026-07-28 | Warnings, Adverse reactions | 2968PHW8QP |
| DERMFREE INSECT BITE RELIEF | SODIUM BICARBONATE 5% INSECT BITE RELIEF | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 5794886c-0d74-9f35-e063-6394a90a27d8 | 2026-07-27 | Warnings | 8MDF5V39QO |
| 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 |
| Neutraflush | EYEWASH STATION ADDITIVE CONCENTRATE | Aero Healthcare | 1d9ff2ef-9c9b-f367-e063-6294a90afa0e | 2026-07-24 | Warnings | 6DC9Q167V3 |
| PEG 3350 and Electrolytes | POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE | A-S Medication Solutions | 19daf830-7270-4661-81b1-ded38f867f28 | 2026-07-24 | Warnings, Adverse reactions | 8MDF5V39QO |
| 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 |
| GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPS | POLYVINYL ALCOHOL, POVIDONE | AmerisourceBergen | ce6852a8-c5e6-403d-a7b4-a2e85d1ebb1f | 2026-07-22 | Warnings | 532B59J990 |
| 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 |
| 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 |
| FUNGAL NAIL TREATMENT kit .cream. | PSEUDOLARIX AMABILIS BARK 1% | GETHSEMANE BRANCH CORPORATION | 56c9d9fa-09ad-e26a-e063-6394a90a0ed9 | 2026-07-17 | Warnings | 6DC9Q167V3 |
| Eyewash Station Additive Concentrate | CHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOL | Global Equipment Company | bc93a1e8-aa3c-6735-e053-2995a90ad6e8 | 2026-07-16 | Warnings | 6DC9Q167V3 |
| Revitalize Energizing Eye Drops | NAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOL | Revitalize Energy Inc. | 518aac87-1642-4b2f-bca1-b74d21261eea | 2026-07-16 | Warnings | 6DC9Q167V3 |
| DABIGATRAN | DABIGATRAN ETEXILATE | American Health Packaging | f7ea7e2c-ca54-4ecc-9fc7-bd3571b0ebc2 | 2026-07-15 | Boxed warning, Warnings, Adverse reactions | 1037045 1037179 SC7NUW5IIT |
| dabigatran etexilate | DABIGATRAN ETEXILATE | Apotex Corp. | dd47a015-ff90-d7a7-8dcb-4e6e31a68071 | 2026-07-13 | Boxed warning, Warnings, Adverse reactions | 1723476 1037045 1037179 SC7NUW5IIT |
| Sodium Bicarbonate | SODIUM BICARBONATE | Amneal Pharmaceuticals Private Limited | ac91e834-e693-43a2-829b-56793453e8cc | 2026-07-09 | Warnings, Adverse reactions | 8MDF5V39QO |
| Bombee Honey Daily Glow Shield Sunscreen | HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE | ABT ASIA Inc. | 56112dff-b091-7a56-e063-6294a90a77d3 | 2026-07-08 | Warnings | 15FIX9V2JP |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.