dabigatran

Generic: dabigatran etexilate

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dabigatran
Generic Name dabigatran etexilate
Labeler avpak
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dabigatran etexilate mesylate 150 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-200
Product ID 50268-200_43cbae6c-3c71-51aa-e063-6394a90a6d9a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213879
Listing Expiration 2026-12-31
Marketing Start 2025-07-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268200
Hyphenated Format 50268-200

Supplemental Identifiers

RxCUI
1037045
UNII
SC7NUW5IIT

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 (source: ndc)
Generic Name dabigatran etexilate (source: ndc)
Application Number ANDA213879 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 BLISTER PACK in 1 BOX (50268-200-16) / 1 CAPSULE in 1 BLISTER PACK (50268-200-11)
source: ndc

Packages (1)

50268-200-16 60 BLISTER PACK in 1 BOX (50268-200-16) / 1 CAPSULE in 1 BLISTER PACK (50268-200-11)

Ingredients (1)

dabigatran etexilate mesylate (150 mg/1)

Linked Drug Pages (1)

DABIGATRAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43cbae6c-3c71-51aa-e063-6394a90a6d9a", "openfda": {"unii": ["SC7NUW5IIT"], "rxcui": ["1037045"], "spl_set_id": ["39ac558a-b375-f3c1-e063-6394a90aa901"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "60 BLISTER PACK in 1 BOX (50268-200-16)  / 1 CAPSULE in 1 BLISTER PACK (50268-200-11)", "package_ndc": "50268-200-16", "marketing_start_date": "20250712"}], "brand_name": "DABIGATRAN", "product_id": "50268-200_43cbae6c-3c71-51aa-e063-6394a90a6d9a", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "50268-200", "generic_name": "DABIGATRAN ETEXILATE", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DABIGATRAN", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "150 mg/1"}], "application_number": "ANDA213879", "marketing_category": "ANDA", "marketing_start_date": "20250712", "listing_expiration_date": "20261231"}