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 36 of 124 · 2,462 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunscreen Lotion118mlZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4620c41a-2188-00f5-e063-6394a90a613c2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen CreamZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46224dbe-a0fb-c242-e063-6394a90a26342025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Perricone High Potency Face Finishing and Firming MoisturizerTITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC2409cea1-7077-dc12-e063-6294a90a45582025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC3635a073-5484-f96c-e063-6394a90adef52025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen LipTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC36362dc7-31d7-f766-e063-6294a90a129b2025-12-17Exact identifier
unii: 15FIX9V2JP
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski36480f7f-37e8-decd-e063-6394a90ada602025-12-17Exact identifier
unii: 15FIX9V2JP
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski364827bd-5781-eb53-e063-6394a90ab22f2025-12-17Exact identifier
unii: 15FIX9V2JP
non-tinted face mineral sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649bf1a-17c3-fe0b-e063-6294a90a13c02025-12-17Exact identifier
unii: 15FIX9V2JP
Tinted Mattifying Face Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649f634-8bcd-b3c1-e063-6394a90a49d92025-12-17Exact identifier
unii: 15FIX9V2JP
tinted lip mineral sunscreen SPF45TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing364b023b-4a52-225a-e063-6394a90ad1972025-12-17Exact identifier
unii: 15FIX9V2JP
ULTAMATTE PROTECTION SUNSCREENTITANIUM DIOXIDE, ZINC OXIDESKINFINITY37efc466-17b8-9f7b-e063-6294a90a8c882025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3cce3120-748e-a7fd-e063-6394a90a4d512025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3d5a2662-02e3-3a95-e063-6294a90a81202025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJKH Aesthetics LLC369ccb8f-d9b6-1fd2-e063-6394a90ace202025-12-17Exact identifier
unii: 15FIX9V2JP
Mattifying Mineral SPF40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d4f6a7-1115-1efa-e063-6294a90a20c42025-12-17Exact identifier
unii: 15FIX9V2JP
Mattifying Mineral SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d45700-fc41-ef54-e063-6394a90abcc32025-12-17Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d85902-fbd2-ba74-e063-6294a90acfc32025-12-17Exact identifier
unii: 15FIX9V2JP
DAY DEFENSETITANIUM DIOXIDE, ZINC OXIDETHE SKIN CARE SOURCE, INC.36ad1330-a8bf-e8f8-e063-6394a90acb022025-12-17Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d9a8f3-7760-57f3-e063-6394a90a1a1e2025-12-17Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d7a18b-5a12-84a9-e063-6394a90a7e382025-12-17Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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