dabigatran etexilate

Generic: dabigatran etexilate

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dabigatran etexilate mesylate 150 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-239
Product ID 72603-239_450cc975-a89f-2a41-e063-6394a90aefcf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207961
Listing Expiration 2026-12-31
Marketing Start 2025-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603239
Hyphenated Format 72603-239

Supplemental Identifiers

RxCUI
1037045
UPC
0372603239010
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
  • 150 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (72603-239-01)
source: ndc

Packages (1)

72603-239-01 60 CAPSULE in 1 BOTTLE (72603-239-01)

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": "450cc975-a89f-2a41-e063-6394a90aefcf", "openfda": {"upc": ["0372603239010"], "unii": ["SC7NUW5IIT"], "rxcui": ["1037045"], "spl_set_id": ["d5937f27-88c7-4c4a-801e-4c8945008982"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (72603-239-01)", "package_ndc": "72603-239-01", "marketing_start_date": "20251201"}], "brand_name": "Dabigatran Etexilate", "product_id": "72603-239_450cc975-a89f-2a41-e063-6394a90aefcf", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "72603-239", "generic_name": "Dabigatran Etexilate", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dabigatran Etexilate", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "150 mg/1"}], "application_number": "ANDA207961", "marketing_category": "ANDA", "marketing_start_date": "20251201", "listing_expiration_date": "20261231"}