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 110 of 122 · 2,425 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1NOCTISALATE, TITANIUM DIOXIDEGuerlaina143c8cb-185c-4fd8-a901-3c0d9ffb82902023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1COCTISALATE, TITANIUM DIOXIDEGuerlain3d6e438d-9ea4-4253-9153-748d3c9742652023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2NOCTISALATE, TITANIUM DIOXIDEGuerlain173aeaab-a286-48ed-9033-10b13f547bbd2023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3.5NOCTISALATE, TITANIUM DIOXIDEGuerlaind877575a-25f3-49bd-b403-ecf6a1eb483a2023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 5NOCTISALATE, TITANIUM DIOXIDEGuerlain24e1e576-9edd-45aa-a883-2a2d18a1cb5e2023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 6NOCTISALATE, TITANIUM DIOXIDEGuerlaina8fffe38-5f90-4078-b553-30036659a2ee2023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7NOCTISALATE, TITANIUM DIOXIDEGuerlainbfa2b2be-958c-439f-b363-2623df2b85012023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3NOCTISALATE, TITANIUM DIOXIDEGuerlain15f73322-0b27-4412-b368-84bc768f55e82023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2WOCTISALATE, TITANIUM DIOXIDEGuerlain51392fe6-fbbb-4ea9-a7aa-98e1711eaa5d2023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4NOCTISALATE, TITANIUM DIOXIDEGuerlainb70b8ffc-091a-4969-86a7-6c3e1b9b9d742023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3WOCTISALATE, TITANIUM DIOXIDEGuerlain15fe0429-720c-4975-953d-285aa7ee12ce2023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4WOCTISALATE, TITANIUM DIOXIDEGuerlain1a733548-75a4-41ec-8d8d-3e6e9aad52e02023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 8NOCTISALATE, TITANIUM DIOXIDEGuerlainf43c867a-161f-47b7-b3d8-7f7e6c6728042023-11-08WarningsExact identifier
unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0COCTISALATE, TITANIUM DIOXIDEGuerlain0d75be99-7607-4964-bb6e-3c731644ab4e2023-11-08WarningsExact identifier
unii: 15FIX9V2JP
SANTO REMEDIOS Piel Eterna Radiance Sunscreen Primer SPF-42TITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC82d210bc-b7ca-4d74-be58-85f175a750582023-11-06WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen SPF-30TITANIUM DIOXIDE, ZINC OXIDENEWCO LLCfa3c73a3-0dfb-4673-822a-45d946dee2602023-11-06WarningsExact identifier
unii: 15FIX9V2JP
RADIANCE Silky Mineral Primer Sunscreen SPF-42 HONEYTITANIUM DIOXIDE, ZINC OXIDESANTO REMEDIO LLC867a88df-9a18-447f-8301-2ec91566302e2023-11-06WarningsExact identifier
unii: 15FIX9V2JP
KOVR All-Natural SPF-30 Moisturizing Sunscreen for MenTITANIUM DIOXIDE, ZINC OXIDEACTIVE LIFE INCbf766aab-a52d-41e8-a06a-f2e536d2219b2023-11-06WarningsExact identifier
unii: 15FIX9V2JP
PROJECT REEF SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC6bcd470c-6994-4d28-8370-4cc9d68e1e782023-11-06WarningsExact identifier
unii: 15FIX9V2JP
BB OSKIN Broad Spectrum SPF-30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NYd84cca38-b673-484e-aa25-df58d904d4d32023-11-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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