dabigatran etexilate

Generic: dabigatran etexilate

Labeler: dr.reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dabigatran etexilate
Generic Name dabigatran etexilate
Labeler dr.reddys laboratories inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

dabigatran etexilate mesylate 110 mg/1

Manufacturer
Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-453
Product ID 43598-453_e9e8ec3b-2d7e-31cc-6268-60e4da2236ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208048
Listing Expiration 2026-12-31
Marketing Start 2025-02-28

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598453
Hyphenated Format 43598-453

Supplemental Identifiers

RxCUI
1037045 1037179 1723476
UPC
0343598641607 0343598642604 0343598453606
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 ANDA208048 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 110 mg/1
source: ndc
Packaging
  • 60 CAPSULE in 1 BOTTLE (43598-453-60)
source: ndc

Packages (1)

43598-453-60 60 CAPSULE in 1 BOTTLE (43598-453-60)

Ingredients (1)

dabigatran etexilate mesylate (110 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": "e9e8ec3b-2d7e-31cc-6268-60e4da2236ba", "openfda": {"upc": ["0343598641607", "0343598642604", "0343598453606"], "unii": ["SC7NUW5IIT"], "rxcui": ["1037045", "1037179", "1723476"], "spl_set_id": ["a608e019-db9a-d6fb-cd0d-cecc1351a2b1"], "manufacturer_name": ["Dr.Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE in 1 BOTTLE (43598-453-60)", "package_ndc": "43598-453-60", "marketing_start_date": "20250228"}], "brand_name": "Dabigatran etexilate", "product_id": "43598-453_e9e8ec3b-2d7e-31cc-6268-60e4da2236ba", "dosage_form": "CAPSULE", "pharm_class": ["Direct Thrombin Inhibitor [EPC]", "Thrombin Inhibitors [MoA]"], "product_ndc": "43598-453", "generic_name": "Dabigatran etexilate", "labeler_name": "Dr.Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dabigatran etexilate", "active_ingredients": [{"name": "DABIGATRAN ETEXILATE MESYLATE", "strength": "110 mg/1"}], "application_number": "ANDA208048", "marketing_category": "ANDA", "marketing_start_date": "20250228", "listing_expiration_date": "20261231"}