tranexamic acid

Generic: tranexamic acid

Labeler: avenacy, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

tranexamic acid 100 mg/mL

Manufacturer
Avenacy, Inc.

Identifiers & Regulatory

Product NDC 83634-401
Product ID 83634-401_5dece4b5-d95e-4fe7-b0ed-89bd573f2fad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203521
Listing Expiration 2026-12-31
Marketing Start 2024-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83634401
Hyphenated Format 83634-401

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 ANDA203521 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-401-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-401-41)
source: ndc

Packages (1)

83634-401-10 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-401-10) / 10 mL in 1 VIAL, SINGLE-DOSE (83634-401-41)

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": "5dece4b5-d95e-4fe7-b0ed-89bd573f2fad", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["00630e54-0e84-465d-96a5-63486c87dcd9"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Avenacy, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-401-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (83634-401-41)", "package_ndc": "83634-401-10", "marketing_start_date": "20240601"}], "brand_name": "tranexamic acid", "product_id": "83634-401_5dece4b5-d95e-4fe7-b0ed-89bd573f2fad", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "83634-401", "generic_name": "tranexamic acid", "labeler_name": "Avenacy, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tranexamic acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "100 mg/mL"}], "application_number": "ANDA203521", "marketing_category": "ANDA", "marketing_start_date": "20240601", "listing_expiration_date": "20261231"}