dabigatran etexilate

Generic: dabigatran etexilate

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dabigatran etexilate
Generic Name dabigatran etexilate
Labeler ascend laboratories, llc
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

dabigatran etexilate mesylate 75 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-474
Product ID 67877-474_dd84fc7b-8d68-4a2b-ab48-9458f6586160
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208040
Listing Expiration 2026-12-31
Marketing Start 2022-06-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877474
Hyphenated Format 67877-474

Supplemental Identifiers

RxCUI
1037045 1037179 1723476
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 ANDA208040 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 75 mg/1
source: ndc
Packaging
  • 60 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-474-60)
source: ndc

Packages (1)

67877-474-60 60 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-474-60)

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": "dd84fc7b-8d68-4a2b-ab48-9458f6586160", "openfda": {"unii": ["SC7NUW5IIT"], "rxcui": ["1037045", "1037179", "1723476"], "spl_set_id": ["3a8ec82a-c367-40dc-9302-e1896fcb05ea"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-474-60)", "package_ndc": "67877-474-60", "marketing_start_date": "20220620"}], "brand_name": "Dabigatran Etexilate", "product_id": "67877-474_dd84fc7b-8d68-4a2b-ab48-9458f6586160", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "67877-474", "generic_name": "Dabigatran Etexilate", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dabigatran Etexilate", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "75 mg/1"}], "application_number": "ANDA208040", "marketing_category": "ANDA", "marketing_start_date": "20220620", "listing_expiration_date": "20261231"}