tranexamic acid

Generic: tranexamic acid

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler apotex corp.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 100 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-6169
Product ID 60505-6169_9002dad4-1b99-59ce-1c71-810a1821f0d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209860
Listing Expiration 2026-12-31
Marketing Start 2020-08-05

Pharmacologic Class

Established (EPC)
antifibrinolytic agent [epc]
Physiologic Effect
decreased fibrinolysis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056169
Hyphenated Format 60505-6169

Supplemental Identifiers

RxCUI
238720
UNII
6T84R30KC1
NUI
N0000175634 N0000175632

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 tranexamic acid (source: ndc)
Generic Name tranexamic acid (source: ndc)
Application Number ANDA209860 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (60505-6169-1) / 10 mL in 1 VIAL
source: ndc

Packages (1)

60505-6169-1 10 VIAL in 1 CARTON (60505-6169-1) / 10 mL in 1 VIAL

Ingredients (1)

tranexamic acid (100 mg/mL)

Linked Drug Pages (1)

Tranexamic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9002dad4-1b99-59ce-1c71-810a1821f0d3", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["a93d6ef3-e160-db0d-142f-9b91af8d8428"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (60505-6169-1)  / 10 mL in 1 VIAL", "package_ndc": "60505-6169-1", "marketing_start_date": "20200805"}], "brand_name": "Tranexamic Acid", "product_id": "60505-6169_9002dad4-1b99-59ce-1c71-810a1821f0d3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "60505-6169", "generic_name": "tranexamic acid", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tranexamic Acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "100 mg/mL"}], "application_number": "ANDA209860", "marketing_category": "ANDA", "marketing_start_date": "20200805", "listing_expiration_date": "20261231"}