FDA.reportPublic FDA data

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 table
LabelManufacturerEffective dateType
Dabigatran Etexilate - Major Pharmaceuticals | Alkem Laboratories LimitedMajor Pharmaceuticals | Alkem Laboratories Limited2025-06-12Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7253-04Dabigatran Etexilate3 in 1 CARTONCAPSULE, COATED PELLETS32
0904-7253-35Dabigatran Etexilate10 in 1 BLISTER PACKCAPSULE, COATED PELLETS102
0904-7253-68Dabigatran Etexilate6 in 1 CARTONCAPSULE, COATED PELLETS62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7253DABIGATRAN ETEXILATE CAPSULE, COATED PELLETS [MAJOR PHARMACEUTICALS]1Current NDC, 3 package rows20250515_b76b79ce-b7dd-4390-b40e-71ae6c477d10.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7253-04EA - Each0904-7253b5410e85-ccc2-4a3b-add3-7ae457359e3512025-05-14
0904-7253-35EA - Each0904-7253e9fe4203-0a1f-4844-9a60-5fe2c007f40d12025-05-14
0904-7253-68EA - Each0904-7253b8e42253-9fcb-4b5e-872e-6258a83d9eca12025-05-14

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.

Matched openFDA labels page 102 of 124 · 2,462 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brush On Block Sun Shine SPF 30 Protective Lip Oil Nude TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e5493f-6478-0ff4-e063-6394a90af4f52024-03-05WarningsExact identifier
unii: 15FIX9V2JP
Brush On Block Sun Shine SPF 30 Protective Lip Oil CoralTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e65634-2e6d-b030-e063-6294a90ad1c42024-03-05WarningsExact identifier
unii: 15FIX9V2JP
Brush On Block Sun Shine SPF 30 Protective Lip Oil FigTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC12e7507d-6612-fda4-e063-6294a90a1db72024-03-05WarningsExact identifier
unii: 15FIX9V2JP
Sodium BicarbonateSODIUM BICARBONATESteriscience Specialties Private Limitedeb2996b4-c04c-4678-b8a9-5cbbe509bb702024-03-04Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsExact identifier
unii: 8MDF5V39QO
BB Tint 30 BS SPF 30ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs1212448c-db88-26e6-e063-6294a90a3b9e2024-02-23WarningsExact identifier
unii: 15FIX9V2JP
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirsta5eedf57-2783-b3d0-e053-2a95a90a9ff52024-02-22Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -DEEPHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarinsbf31d19d-9520-4ac0-a4fd-2c285545f1b82024-02-20WarningsExact identifier
unii: 15FIX9V2JP
Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint MediumHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarins2c0964cd-607c-4219-b66e-cc99ada804342024-02-20WarningsExact identifier
unii: 15FIX9V2JP
CLARINS UV PLUS ANTI-POLLUTION SUNSCREEN MULTI-PROTECTION BROAD SPECTRUM SPF 50 Oil-Free -LIGHTHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDELaboratoires Clarins6259442e-0c39-4887-8083-89253b64b5ff2024-02-20WarningsExact identifier
unii: 15FIX9V2JP
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H Co., Ltd.11c37acc-abb8-8c38-e063-6294a90a79322024-02-19WarningsExact identifier
unii: 15FIX9V2JP
GANGNAM Glow Day Shield Perfect Sunscreen SPF 50OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltd11c461f7-0f34-65ff-e063-6294a90a3da72024-02-19WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen Beige Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.711aa92c-81b0-42e4-b83f-9ce95116ec032024-02-16WarningsExact identifier
unii: 15FIX9V2JP
Atomy Sunscreen White Broad Spectrum SPF 50 PLUSHOMOSALATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEATOMY CO., LTD.b8bc0021-bb4d-45f2-a570-3f2e61edf21d2024-02-16WarningsExact identifier
unii: 15FIX9V2JP
Sheet SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma Inc.bbb5b87c-d641-3ba2-e053-2a95a90a0f702024-02-14WarningsExact identifier
unii: 15FIX9V2JP
sheer tint SPF 45BROAD SPECTRUMCP Skin Health Group, Inc.b7c5cedd-ff68-74de-e053-2a95a90a37962024-02-14WarningsExact identifier
unii: 15FIX9V2JP
REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/OOCTINOXATE, TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10f7ec01-541b-a15a-e063-6294a90aa9df2024-02-09WarningsExact identifier
unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden HourTITANIUM DIOXIDECOOLA, LLCedfda0f5-0f72-5cc7-e053-2a95a90ae38d2024-02-02WarningsExact identifier
unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Summer CrushZINC OXIDECOOLA, LLCedc6754e-dabb-5bff-e053-2a95a90a73902024-02-02WarningsExact identifier
unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Skinny DipZINC OXIDECOOLA, LLCee01f936-81a9-a54d-e053-2a95a90a52272024-02-02WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.