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 63 of 124 · 2,462 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e l f Camo Semi Matte CC SPF 30 Rich 640 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.cbf949b3-e640-48eb-acf6-fccd6f2588652025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 650 CZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.b8bfad36-54b7-42f3-bb5b-5eda1a10f0212025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Rich 660 NZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.853100ea-a9dc-43eb-9715-125b543d2be02025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Tan 400 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.e4f2b579-4886-4e20-a527-c033e9d60bf52025-10-31WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Tan 460 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.49255019-fa24-4667-b527-ef7189a51f122025-10-31WarningsExact identifier
unii: 15FIX9V2JP
Dabigatran EtexilateDABIGATRAN ETEXILATEAlembic Pharmaceuticals Inc.834a3c5f-b723-4bcb-a560-dc305dd0d8292025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1723476
rxcui: 1037045
rxcui: 1037179
unii: SC7NUW5IIT
Clove Hill Tinted Mineral Sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCeb2ff5a7-384f-4379-b149-47c1c8c2291d2025-10-30WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLCa37db64d-8b79-40f4-843f-f38949c5b9d22025-10-30WarningsExact identifier
unii: 15FIX9V2JP
MOOYAM Dark Skin SunscreenSUNSCREENGuangdong Bisutang Biotechnology Co., LTD4246e9f1-1c51-d888-e063-6394a90abda02025-10-29WarningsExact identifier
unii: 15FIX9V2JP
non-tinted mineral sunscreenTITANIUM DIOXIDE, ZINC OXIDEClove Hill LLC311b270f-b9e2-2374-e063-6294a90af5812025-10-29WarningsExact identifier
unii: 15FIX9V2JP
Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23f4cf41-0eed-2df3-e063-6294a90ad4022025-10-28WarningsExact identifier
unii: 15FIX9V2JP
TIBENA EVERYTHING MULTI CUSHION SPF50HOMOSALATE, TITANIUM DIOXIDEKONAD CO LTD421eda8f-62b2-30fb-e063-6394a90a49472025-10-27WarningsExact identifier
unii: 15FIX9V2JP
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: 532B59J990
PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30TITANIUM DIOXIDETHG Beauty USA LLC397b4338-fec8-5228-e063-6394a90ad97d2025-10-23WarningsExact identifier
unii: 15FIX9V2JP
Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30TITANIUM DIOXIDETHG Beauty USA LLC38c80373-1d5a-c7f4-e063-6294a90aa9c22025-10-23WarningsExact identifier
unii: 15FIX9V2JP
Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35ZINC OXIDE, TITANIUM DIOXIDETHG Beauty USA LLC254b4692-a459-6119-e063-6394a90a0a602025-10-23WarningsExact identifier
unii: 15FIX9V2JP
Advanced Eye Relief Dry Eye RejuvenationGLYCERIN PROPYLENE GLYCOLBausch & Lomb Incorporated027969ee-64e4-4b08-bab7-c4cc8ed22f5f2025-10-23WarningsExact identifier
unii: 6DC9Q167V3
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 LatteOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc34c1486-fa6c-485f-80b3-98e397b3dddb2025-10-22WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool VanillaOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS74c078ec-a371-4406-8d5e-a0baada3a1a62025-10-22WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 SandalwoodOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2765f345-eab2-4878-b1f1-f8e2430834762025-10-22WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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