dabigatran etexilate

Generic: dabigatran etexilate

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

Drug Facts

Product Profile

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

dabigatran etexilate mesylate 150 mg/1

Manufacturer
Alembic Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 62332-636
Product ID 62332-636_7057c0da-54c3-4021-a4de-e948a7684dc2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215233
Listing Expiration 2026-12-31
Marketing Start 2024-06-14

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62332636
Hyphenated Format 62332-636

Supplemental Identifiers

RxCUI
1037045 1037179 1723476
UPC
0362332636600 0362332634606
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 ANDA215233 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (62332-636-06) / 6 CAPSULE in 1 BLISTER PACK
  • 180 CAPSULE in 1 BOTTLE (62332-636-45)
  • 60 CAPSULE in 1 BOTTLE (62332-636-60)
source: ndc

Packages (3)

62332-636-06 10 BLISTER PACK in 1 CARTON (62332-636-06) / 6 CAPSULE in 1 BLISTER PACK 62332-636-45 180 CAPSULE in 1 BOTTLE (62332-636-45) 62332-636-60 60 CAPSULE in 1 BOTTLE (62332-636-60)

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": "7057c0da-54c3-4021-a4de-e948a7684dc2", "openfda": {"upc": ["0362332636600", "0362332634606"], "unii": ["SC7NUW5IIT"], "rxcui": ["1037045", "1037179", "1723476"], "spl_set_id": ["834a3c5f-b723-4bcb-a560-dc305dd0d829"], "manufacturer_name": ["Alembic Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (62332-636-06)  / 6 CAPSULE in 1 BLISTER PACK", "package_ndc": "62332-636-06", "marketing_start_date": "20240614"}, {"sample": false, "description": "180 CAPSULE in 1 BOTTLE (62332-636-45)", "package_ndc": "62332-636-45", "marketing_start_date": "20251008"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (62332-636-60)", "package_ndc": "62332-636-60", "marketing_start_date": "20240614"}], "brand_name": "Dabigatran Etexilate", "product_id": "62332-636_7057c0da-54c3-4021-a4de-e948a7684dc2", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "62332-636", "generic_name": "Dabigatran Etexilate", "labeler_name": "Alembic Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dabigatran Etexilate", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "150 mg/1"}], "application_number": "ANDA215233", "marketing_category": "ANDA", "marketing_start_date": "20240614", "listing_expiration_date": "20261231"}