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 40 of 124 · 2,462 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543e85d-9bc7-b8ed-e063-6294a90ae7d32025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bc8593d-fc6c-04aa-e063-6394a90a6d562025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMantra Wellness Spa3389b0a3-40f9-b411-e063-6394a90a99592025-12-15Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39959db9-5ee1-a27c-e063-6394a90a1e102025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995f556-20fe-3e64-e063-6294a90a5efe2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995385b-b10b-ca5c-e063-6294a90af43f2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3994aa84-30b4-3dc4-e063-6394a90a23e72025-12-15Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39947913-f1cc-25d2-e063-6294a90a42292025-12-15Exact identifier
unii: 15FIX9V2JP
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357ff025-84ad-6d77-e063-6394a90aad952025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY358021a2-235b-825b-e063-6394a90a76f52025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Physical DefenseTITANIUM DIOXIDE, ZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35477ed2-0875-58d5-e063-6294a90a3d5d2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35a97770-2db9-99aa-e063-6294a90a459a2025-12-15Exact identifier
unii: 15FIX9V2JP
Non-Tinted Sports StickTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35aa833a-19a1-99e9-e063-6394a90a840f2025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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