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 87 of 124 · 2,462 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Light Illusion Luminous Makeup Nude-Skin Feel SPF18- D2 NUTMEGOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29abae8f-53db-b592-e063-6294a90adabb2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 MOCHAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29aba80c-55b7-b8d9-e063-6294a90a5cc12024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 COCOAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29abe97b-e9b3-6e27-e063-6294a90ae3ed2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 DEEP GOLDENOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29abdf3c-fb54-a5e3-e063-6394a90af4502024-12-19WarningsExact identifier
unii: 15FIX9V2JP
CeraVe Developed with Dermatologists Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Face Sheer Tint SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products, Inc.f2e34230-7bfb-455f-8b33-6bff96fd9f0a2024-12-19WarningsExact identifier
unii: 15FIX9V2JP
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SHELLOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29868d60-b900-e0ad-e063-6294a90af87a2024-12-18WarningsExact identifier
unii: 15FIX9V2JP
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50 JasmineTITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasole999d752-6c00-459e-b6c3-d264c330597d2024-12-18WarningsExact identifier
unii: 15FIX9V2JP
Belasol Suncream Non Tinted Moisturizing Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEEK Clothing LLC dba Belasolf22626c1-0996-41d8-a2ec-3bf7491df6572024-12-18WarningsExact identifier
unii: 15FIX9V2JP
EcoDent Ultimate Essential Mouthcare Sparkling Clean MintSODIUM BICARBONATELotus Brands, Inc.4a95c8c1-db7c-4791-ac58-3eac216a01262024-12-18WarningsExact identifier
unii: 8MDF5V39QO
EcoDent Ultimate Essential Mouthcare Spicy-Cool CinnamonSODIUM BICARBONATELotus Brands, Inc.6703b29d-cdc9-4c74-91c0-fb0c98dd043e2024-12-18WarningsExact identifier
unii: 8MDF5V39QO
SPF 50 plus Sunscreen All Mineral Active IngredientsTITANIUM DIOXIDE AND ZINC OXIDEKAS Direct LLC dba BabyGanics247aae3d-1845-4dd8-b774-b9e8214809a22024-12-18WarningsExact identifier
unii: 15FIX9V2JP
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
unii: 8MDF5V39QO
STUDIO FIX FLUID BROAD SPECTRUM SPF 15OCTINOXATE, TITANIUM DIOXIDEMAKEUP ART COSMETICSfb59afc1-1dc9-f783-e053-6394a90a196b2024-12-17WarningsExact identifier
unii: 15FIX9V2JP
MAC STUDIO WATERWEIGHT SPF 30 BROAD SPECTRUM FOUNDATION SUNSCREENOCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEMAKEUP ART COSMETICSe5fd3e40-de1d-4cdd-b725-4a517514ca352024-12-17WarningsExact identifier
unii: 15FIX9V2JP
STUDIO FINISH CONCEALER BROAD SPECTRUM SPF 35OCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICS2d034810-7210-4ad4-be23-ec2100f8c2f12024-12-17WarningsExact identifier
unii: 15FIX9V2JP
Cerave Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Deep Sheer TintTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inca1cab79d-0151-49ee-86dc-c2739842e62e2024-12-17WarningsExact identifier
unii: 15FIX9V2JP
SPF 50 plus SunscreenTITANIUM DIOXIDE, OCTISALATE, AND ZINC OXIDEKAS Direct LLC dba BabyGanics5a4c71fc-aa6f-47f7-8d1d-2af2e726cf9b2024-12-17WarningsExact identifier
unii: 15FIX9V2JP
Even Up Sunscreen SPF 50TITANIUM DIOXIDE AND ZINC OXIDEColoresciencef9d375af-3c8b-4462-b729-fdd4be9292842024-12-17WarningsExact identifier
unii: 15FIX9V2JP
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 40OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEBobbi Brown Professional Cosmetics Inc.dc6b28ca-b922-460a-8028-fb3f5afdbe9d2024-12-16WarningsExact identifier
unii: 15FIX9V2JP
BOBBI BROWN INTENSIVE SERUM FOUNDATION BROAD SPECTRUM SPF 30OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDEBobbi Brown Professional Cosmetics Inc.1f9a4b71-45aa-4156-9fe6-ffa81f808a852024-12-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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