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 |
|---|---|---|---|---|---|---|
| SODIUM BICARBONATE | SODIUM BICARBONATE | Medical Purchasing Solutions, LLC | 4f97d398-2118-0874-e063-6394a90a4ad1 | 2026-04-16 | Warnings, Adverse reactions | 8MDF5V39QO |
| PEG 3350 and Electrolytes | POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE | Wilshire Pharmaceuticals, Inc. | b251752d-7750-482a-9364-0acf4ad47cc8 | 2026-04-16 | Warnings, Adverse reactions | 8MDF5V39QO |
| MELAO Hydrating Mineral Sunscreen | TITANIUM DIOXIDE,ZINC OXIDE | Guangdong Aimu Biological Technology Co., Ltd | 4f778eb0-55f7-38d0-e063-6394a90a69a0 | 2026-04-15 | Warnings | 15FIX9V2JP |
| ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 | TITANIUM DIOXIDE, ZINC OXIDE | ZO Skin Health Inc. | 4f81e482-8111-451c-e063-6294a90ad148 | 2026-04-15 | Warnings | 15FIX9V2JP |
| Mineral Lip Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | UNDRBUDR, LLC | 4f8353b3-4ac1-9703-e063-6294a90abdad | 2026-04-15 | Warnings | 15FIX9V2JP |
| Mineral Sunscreen Stick Non-Tinted | TITANIUM DIOXIDE, ZINC OXIDE | UNDRBUDR, LLC | 4f83dd76-a8d8-916e-e063-6294a90ab6ed | 2026-04-15 | Warnings | 15FIX9V2JP |
| Mineral Sunscreen Stick - Tinted | TITANIUM DIOXIDE, ZINC OXIDE | UNDRBUDR, LLC | 4f84619f-3415-7443-e063-6394a90a162a | 2026-04-15 | Warnings | 15FIX9V2JP |
| Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivory | TITANIUM DIOXIDE AND ZINC OXIDE | PML NYC, LLC | 1be639a8-179a-7015-e063-6394a90ab64b | 2026-04-15 | Warnings | 15FIX9V2JP |
| DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30 | DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30 | PML NYC, LLC | ea90bb4d-6f4a-45c9-e053-2a95a90a53a7 | 2026-04-15 | Warnings | 15FIX9V2JP |
| YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- ALABASTER | YOUR NAME MINERAL SHEER TINT | PML NYC, LLC | 0e24a63e-d76f-6581-e063-6394a90a6181 | 2026-04-15 | Warnings | 15FIX9V2JP |
| Sei Bella Tinted BB Moisturizing Cream | 115 N | PML NYC, LLC | 316e8ac6-f8fa-7add-e063-6294a90a4f24 | 2026-04-15 | Warnings | 15FIX9V2JP |
| ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light) | TITANIUM DIOXIDE, ZINC OXIDE | ZO Skin Health Inc. | 4f8756bf-5b0d-5269-e063-6294a90ae6dc | 2026-04-15 | Warnings | 15FIX9V2JP |
| ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Light Medium) | TITANIUM DIOXIDE, ZINC OXIDE | ZO Skin Health Inc. | 4f87e24f-e4ff-03a7-e063-6294a90a23b1 | 2026-04-15 | Warnings | 15FIX9V2JP |
| YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20 Cameo Glow | YOUR NAME MINERAL SHEER TINT | PML NYC, LLC | 316cd602-8af5-fbb6-e063-6294a90a287b | 2026-04-15 | Warnings | 15FIX9V2JP |
| GoLYTELY | POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE | Azurity Pharmaceuticals, Inc. | 7609ecf7-0ce0-4fbb-9c27-30987f689575 | 2026-04-15 | Warnings, Adverse reactions | 8MDF5V39QO |
| TRILYTE | POLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE | Aurobindo Pharma Limited | 79f5e596-8d51-4227-afcc-f5e341150957 | 2026-04-15 | Warnings, Adverse reactions | 8MDF5V39QO |
| PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride | POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE | Wilshire Pharmaceuticals, Inc. | 4e442a72-b13b-4869-8a1d-59356095b091 | 2026-04-14 | Warnings, Adverse reactions | 8MDF5V39QO |
| Sodium Bicarbonate 10 gr. (650 mg) | SODIUM BICARBONATE | Gendose Pharmaceuticals, LLC | 0a0cc46d-372e-4175-932a-065e82d8d353 | 2026-04-13 | Warnings | 8MDF5V39QO |
| BANANA BOAT | TITANIUM DIOXIDE,ZINC OXIDE | Edgewell Personal Care Brands LLC | 4f5896a6-0639-5589-e063-6294a90a45a9 | 2026-04-13 | Warnings | 15FIX9V2JP |
| Artificial Tears Lubricant Eye Drops | GLYCERIN, PROPYLENE GLYCOL | CVS Pharmacy | 28297fee-8185-4869-8f39-5bfbf8bf8bfd | 2026-04-13 | Warnings | 6DC9Q167V3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.