dabigatran

Generic: dabigatran etexilate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dabigatran
Generic Name dabigatran etexilate
Labeler a-s medication solutions
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dabigatran etexilate mesylate 75 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7531
Product ID 50090-7531_2cb97cfe-43f0-43be-93ab-c115b473c6ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213879
Listing Expiration 2026-12-31
Marketing Start 2024-05-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907531
Hyphenated Format 50090-7531

Supplemental Identifiers

RxCUI
1037179
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
  • 75 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (50090-7531-0)
source: ndc

Packages (1)

50090-7531-0 60 CAPSULE in 1 BOTTLE (50090-7531-0)

Ingredients (1)

dabigatran etexilate mesylate (75 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": "2cb97cfe-43f0-43be-93ab-c115b473c6ee", "openfda": {"unii": ["SC7NUW5IIT"], "rxcui": ["1037179"], "spl_set_id": ["bee57f1b-ee5f-4f81-ae6f-ea65ddf9a174"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (50090-7531-0)", "package_ndc": "50090-7531-0", "marketing_start_date": "20250407"}], "brand_name": "DABIGATRAN", "product_id": "50090-7531_2cb97cfe-43f0-43be-93ab-c115b473c6ee", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "50090-7531", "generic_name": "DABIGATRAN ETEXILATE", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DABIGATRAN", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "75 mg/1"}], "application_number": "ANDA213879", "marketing_category": "ANDA", "marketing_start_date": "20240522", "listing_expiration_date": "20261231"}