tranexamic acid

Generic: tranexamic acid

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 100 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-197
Product ID 67457-197_a7994e55-1e4d-45bc-bb2c-52b63e4ad408
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091657
Listing Expiration 2026-12-31
Marketing Start 2011-11-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457197
Hyphenated Format 67457-197

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 ANDA091657 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 PACKAGE (67457-197-10) / 10 mL in 1 VIAL, SINGLE-DOSE (67457-197-00)
source: ndc

Packages (1)

67457-197-10 10 VIAL, SINGLE-DOSE in 1 PACKAGE (67457-197-10) / 10 mL in 1 VIAL, SINGLE-DOSE (67457-197-00)

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": "a7994e55-1e4d-45bc-bb2c-52b63e4ad408", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["6f033f1e-8c78-4c87-b870-6493944315ff"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 PACKAGE (67457-197-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (67457-197-00)", "package_ndc": "67457-197-10", "marketing_start_date": "20111129"}], "brand_name": "Tranexamic Acid", "product_id": "67457-197_a7994e55-1e4d-45bc-bb2c-52b63e4ad408", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "67457-197", "generic_name": "tranexamic acid", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tranexamic Acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "100 mg/mL"}], "application_number": "ANDA091657", "marketing_category": "ANDA", "marketing_start_date": "20111129", "listing_expiration_date": "20261231"}