dabigatran etexilate

Generic: dabigatran etexilate

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dabigatran etexilate
Generic Name dabigatran etexilate
Labeler camber pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dabigatran etexilate mesylate 75 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-621
Product ID 31722-621_3b236998-0037-d34f-e063-6294a90a03f5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207961
Listing Expiration 2026-12-31
Marketing Start 2020-05-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722621
Hyphenated Format 31722-621

Supplemental Identifiers

RxCUI
1037045 1037179 1723476
UPC
0331722621601 0331722622608 0331722666602
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 ANDA207961 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (31722-621-32) / 6 CAPSULE in 1 BLISTER PACK
  • 60 CAPSULE in 1 BOTTLE (31722-621-60)
source: ndc

Packages (2)

31722-621-32 10 BLISTER PACK in 1 CARTON (31722-621-32) / 6 CAPSULE in 1 BLISTER PACK 31722-621-60 60 CAPSULE in 1 BOTTLE (31722-621-60)

Ingredients (1)

dabigatran etexilate mesylate (75 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": "3b236998-0037-d34f-e063-6294a90a03f5", "openfda": {"upc": ["0331722621601", "0331722622608", "0331722666602"], "unii": ["SC7NUW5IIT"], "rxcui": ["1037045", "1037179", "1723476"], "spl_set_id": ["3c24e235-218b-438e-9456-42c18ff01913"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (31722-621-32)  / 6 CAPSULE in 1 BLISTER PACK", "package_ndc": "31722-621-32", "marketing_start_date": "20250203"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (31722-621-60)", "package_ndc": "31722-621-60", "marketing_start_date": "20200506"}], "brand_name": "Dabigatran Etexilate", "product_id": "31722-621_3b236998-0037-d34f-e063-6294a90a03f5", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "31722-621", "generic_name": "Dabigatran Etexilate", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dabigatran Etexilate", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "75 mg/1"}], "application_number": "ANDA207961", "marketing_category": "ANDA", "marketing_start_date": "20200506", "listing_expiration_date": "20261231"}