dabigatran etexilate

Generic: dabigatran etexilate

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

Drug Facts

Product Profile

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

dabigatran etexilate mesylate 75 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-634
Product ID 46708-634_4f8d4596-bc1a-48a1-8f6a-caf816a2037f
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 46708634
Hyphenated Format 46708-634

Supplemental Identifiers

RxCUI
1037045 1037179 1723476
UPC
0346708634605 0346708636609
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
  • 75 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 CARTON (46708-634-06) / 6 CAPSULE in 1 BLISTER PACK
  • 60 CAPSULE in 1 BOTTLE (46708-634-60)
source: ndc

Packages (2)

46708-634-06 10 BLISTER PACK in 1 CARTON (46708-634-06) / 6 CAPSULE in 1 BLISTER PACK 46708-634-60 60 CAPSULE in 1 BOTTLE (46708-634-60)

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": "4f8d4596-bc1a-48a1-8f6a-caf816a2037f", "openfda": {"upc": ["0346708634605", "0346708636609"], "unii": ["SC7NUW5IIT"], "rxcui": ["1037045", "1037179", "1723476"], "spl_set_id": ["13649035-a498-4e31-a7ea-8b18cedceca7"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (46708-634-06)  / 6 CAPSULE in 1 BLISTER PACK", "package_ndc": "46708-634-06", "marketing_start_date": "20240614"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (46708-634-60)", "package_ndc": "46708-634-60", "marketing_start_date": "20240614"}], "brand_name": "Dabigatran Etexilate", "product_id": "46708-634_4f8d4596-bc1a-48a1-8f6a-caf816a2037f", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "46708-634", "generic_name": "Dabigatran Etexilate", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dabigatran Etexilate", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "75 mg/1"}], "application_number": "ANDA215233", "marketing_category": "ANDA", "marketing_start_date": "20240614", "listing_expiration_date": "20261231"}