dabigatran etexilate

Generic: dabigatran etexilate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dabigatran etexilate
Generic Name dabigatran etexilate
Labeler aurobindo pharma limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dabigatran etexilate mesylate 150 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-975
Product ID 59651-975_4b36f34b-c19b-497d-9dd6-5c50404226c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208039
Listing Expiration 2026-12-31
Marketing Start 2025-05-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651975
Hyphenated Format 59651-975

Supplemental Identifiers

RxCUI
1037045 1037179 1723476
UPC
0359651974605
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 ANDA208039 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (59651-975-60)
  • 10 BLISTER PACK in 1 CARTON (59651-975-61) / 6 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

59651-975-60 60 CAPSULE in 1 BOTTLE (59651-975-60) 59651-975-61 10 BLISTER PACK in 1 CARTON (59651-975-61) / 6 CAPSULE in 1 BLISTER PACK

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": "4b36f34b-c19b-497d-9dd6-5c50404226c5", "openfda": {"upc": ["0359651974605"], "unii": ["SC7NUW5IIT"], "rxcui": ["1037045", "1037179", "1723476"], "spl_set_id": ["5b196b1f-408e-4615-b980-9f822adff835"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (59651-975-60)", "package_ndc": "59651-975-60", "marketing_start_date": "20250514"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (59651-975-61)  / 6 CAPSULE in 1 BLISTER PACK", "package_ndc": "59651-975-61", "marketing_start_date": "20250514"}], "brand_name": "DABIGATRAN ETEXILATE", "product_id": "59651-975_4b36f34b-c19b-497d-9dd6-5c50404226c5", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "59651-975", "generic_name": "DABIGATRAN ETEXILATE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DABIGATRAN ETEXILATE", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "150 mg/1"}], "application_number": "ANDA208039", "marketing_category": "ANDA", "marketing_start_date": "20250514", "listing_expiration_date": "20261231"}