dabigatran etexilate

Generic: dabigatran etexilate

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dabigatran etexilate
Generic Name dabigatran etexilate
Labeler apotex corp.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dabigatran etexilate mesylate 150 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4348
Product ID 60505-4348_34169945-6c2a-c534-5f38-eeafa24cd108
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208070
Listing Expiration 2026-12-31
Marketing Start 2024-02-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605054348
Hyphenated Format 60505-4348

Supplemental Identifiers

RxCUI
1037045 1037179 1723476
UPC
0360505434763 0360505434862 0360505434961
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 ANDA208070 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (60505-4348-6)
source: ndc

Packages (1)

60505-4348-6 60 CAPSULE in 1 BOTTLE (60505-4348-6)

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": "34169945-6c2a-c534-5f38-eeafa24cd108", "openfda": {"upc": ["0360505434763", "0360505434862", "0360505434961"], "unii": ["SC7NUW5IIT"], "rxcui": ["1037045", "1037179", "1723476"], "spl_set_id": ["dd47a015-ff90-d7a7-8dcb-4e6e31a68071"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (60505-4348-6)", "package_ndc": "60505-4348-6", "marketing_start_date": "20240213"}], "brand_name": "dabigatran etexilate", "product_id": "60505-4348_34169945-6c2a-c534-5f38-eeafa24cd108", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "60505-4348", "generic_name": "dabigatran etexilate", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "dabigatran etexilate", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "150 mg/1"}], "application_number": "ANDA208070", "marketing_category": "ANDA", "marketing_start_date": "20240213", "listing_expiration_date": "20261231"}