dabigatran

Generic: dabigatran etexilate

Labeler: avkare
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dabigatran etexilate mesylate 75 mg/1

Manufacturer
AvKARE

Identifiers & Regulatory

Product NDC 42291-033
Product ID 42291-033_484c020e-2b6b-98c8-e063-6294a90a1a73
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213879
Listing Expiration 2027-12-31
Marketing Start 2024-11-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42291033
Hyphenated Format 42291-033

Supplemental Identifiers

RxCUI
1037045 1037179
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 (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 (42291-033-60)
source: ndc

Packages (1)

42291-033-60 60 CAPSULE in 1 BOTTLE (42291-033-60)

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": "484c020e-2b6b-98c8-e063-6294a90a1a73", "openfda": {"unii": ["SC7NUW5IIT"], "rxcui": ["1037045", "1037179"], "spl_set_id": ["27e95caf-7938-ef8e-e063-6394a90a6a1a"], "manufacturer_name": ["AvKARE"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (42291-033-60)", "package_ndc": "42291-033-60", "marketing_start_date": "20241127"}], "brand_name": "DABIGATRAN", "product_id": "42291-033_484c020e-2b6b-98c8-e063-6294a90a1a73", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "42291-033", "generic_name": "DABIGATRAN ETEXILATE", "labeler_name": "AvKARE", "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": "20241127", "listing_expiration_date": "20271231"}