dabigatran etexilate

Generic: dabigatran etexilate

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dabigatran etexilate
Generic Name dabigatran etexilate
Labeler major pharmaceuticals
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

dabigatran etexilate mesylate 75 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7253
Product ID 0904-7253_869fd2f3-9357-4148-8b64-0cca96dd5f75
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208040
Listing Expiration 2026-12-31
Marketing Start 2025-06-23

Pharmacologic Class

Classes
direct thrombin inhibitor [epc] thrombin inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047253
Hyphenated Format 0904-7253

Supplemental Identifiers

RxCUI
1037045 1037179 1723476
UPC
0309047253043 0309047255108
UNII
SC7NUW5IIT

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dabigatran etexilate (source: ndc)
Generic Name dabigatran etexilate (source: ndc)
Application Number ANDA208040 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (0904-7253-04) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35)
  • 6 BLISTER PACK in 1 CARTON (0904-7253-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35)
source: ndc

Packages (2)

0904-7253-04 3 BLISTER PACK in 1 CARTON (0904-7253-04) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35) 0904-7253-68 6 BLISTER PACK in 1 CARTON (0904-7253-68) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35)

Ingredients (1)

dabigatran etexilate mesylate (75 mg/1)

Linked Drug Pages (1)

Dabigatran Etexilate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "869fd2f3-9357-4148-8b64-0cca96dd5f75", "openfda": {"upc": ["0309047253043", "0309047255108"], "unii": ["SC7NUW5IIT"], "rxcui": ["1037045", "1037179", "1723476"], "spl_set_id": ["b76b79ce-b7dd-4390-b40e-71ae6c477d10"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0904-7253-04)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35)", "package_ndc": "0904-7253-04", "marketing_start_date": "20250623"}, {"sample": false, "description": "6 BLISTER PACK in 1 CARTON (0904-7253-68)  / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (0904-7253-35)", "package_ndc": "0904-7253-68", "marketing_start_date": "20250623"}], "brand_name": "Dabigatran Etexilate", "product_id": "0904-7253_869fd2f3-9357-4148-8b64-0cca96dd5f75", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "0904-7253", "generic_name": "Dabigatran Etexilate", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dabigatran Etexilate", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "75 mg/1"}], "application_number": "ANDA208040", "marketing_category": "ANDA", "marketing_start_date": "20250623", "listing_expiration_date": "20261231"}