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 20 of 124 · 2,462 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 8N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb0e315b3-a322-4607-b212-bcadd5aa99bc2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 9N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorcc0f19fc-7b6f-4454-9a77-dc11f0fd12512026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 10N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc361a514-5fc9-42a7-b1fc-28e4a11ad7332026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00 NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diordb38ced5-dfbe-4b7e-b4ae-3065df1898b02026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior4ead1ce8-f31d-4676-8619-8d49dd62db2e2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior827caf09-222e-487a-941c-44eb5c13d5d62026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf3c378e1-853b-463e-9fc3-6a54ef8610442026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc3a479c4-807e-4c52-a27f-eea8705b9c1e2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorcb63faaa-82d8-469a-a9a1-88b09e02cc352026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorc20b0b8b-366a-47ff-84b6-264fa8ed6de02026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior31d89246-418d-4ed4-8e32-7aa2422073a92026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior31b74e11-c5e5-4086-baa5-e7a39dc556a02026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior29ec217b-7726-4590-8a0d-e4b08217e2222026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorceabea37-020c-49e0-a049-3100ed46ff572026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior915a0b1f-b26e-4fea-95f3-ccec2bcab3892026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior9a313d8e-003d-4d40-b892-0f2270e4f6c22026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf560de93-4099-4ad9-8eb6-fe2a52ac82a12026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior824c5f13-970e-4e9e-8f2a-2a01973d2e592026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb7621ef5-47fc-4ccc-aedd-eac328ace7b92026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior64a29ff8-e24d-4818-9b54-734a0eb2a13f2026-01-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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