dabigatran etexilate

Generic: dabigatran etexilate

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

Drug Facts

Product Profile

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

dabigatran etexilate mesylate 75 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0265
Product ID 0378-0265_6c6b985e-111f-4fe9-a1ca-785c450e444b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208067
Listing Expiration 2026-12-31
Marketing Start 2025-02-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03780265
Hyphenated Format 0378-0265

Supplemental Identifiers

RxCUI
1037045 1037179
UPC
0303780266933
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 ANDA208067 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0265-91)
source: ndc

Packages (1)

0378-0265-91 60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0265-91)

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": "6c6b985e-111f-4fe9-a1ca-785c450e444b", "openfda": {"upc": ["0303780266933"], "unii": ["SC7NUW5IIT"], "rxcui": ["1037045", "1037179"], "spl_set_id": ["baafb5be-ffe6-4755-a7ab-817b3c9b222d"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE, PLASTIC (0378-0265-91)", "package_ndc": "0378-0265-91", "marketing_start_date": "20250225"}], "brand_name": "Dabigatran Etexilate", "product_id": "0378-0265_6c6b985e-111f-4fe9-a1ca-785c450e444b", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "0378-0265", "generic_name": "Dabigatran Etexilate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dabigatran Etexilate", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "75 mg/1"}], "application_number": "ANDA208067", "marketing_category": "ANDA", "marketing_start_date": "20250225", "listing_expiration_date": "20261231"}