dabigatran etexilate

Generic: dabigatran etexilate

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

Drug Facts

Product Profile

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

dabigatran etexilate mesylate 150 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7657
Product ID 50090-7657_18170616-bb47-48f0-b693-17de14a3c970
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208040
Listing Expiration 2026-12-31
Marketing Start 2022-06-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907657
Hyphenated Format 50090-7657

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

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50090-7657-0)
source: ndc

Packages (1)

50090-7657-0 60 CAPSULE, COATED PELLETS in 1 BOTTLE (50090-7657-0)

Ingredients (1)

dabigatran etexilate mesylate (150 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": "18170616-bb47-48f0-b693-17de14a3c970", "openfda": {"unii": ["SC7NUW5IIT"], "rxcui": ["1037045"], "spl_set_id": ["369b945d-5bda-4773-910a-d0adef7f0f39"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (50090-7657-0)", "package_ndc": "50090-7657-0", "marketing_start_date": "20250918"}], "brand_name": "Dabigatran Etexilate", "product_id": "50090-7657_18170616-bb47-48f0-b693-17de14a3c970", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "50090-7657", "generic_name": "Dabigatran Etexilate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dabigatran Etexilate", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "150 mg/1"}], "application_number": "ANDA208040", "marketing_category": "ANDA", "marketing_start_date": "20220620", "listing_expiration_date": "20261231"}