tranexamic acid

Generic: tranexamic acid

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 100 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1532
Product ID 51662-1532_1035853c-6cb9-76b2-e063-6394a90a3938
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205035
Listing Expiration 2026-12-31
Marketing Start 2021-06-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621532
Hyphenated Format 51662-1532

Supplemental Identifiers

RxCUI
238720
UNII
6T84R30KC1
NUI
N0000175634 N0000175632

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 ANDA205035 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 mL in 1 VIAL, SINGLE-DOSE (51662-1532-1)
  • 10 POUCH in 1 CASE (51662-1532-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1532-2) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

51662-1532-1 10 mL in 1 VIAL, SINGLE-DOSE (51662-1532-1) 51662-1532-3 10 POUCH in 1 CASE (51662-1532-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1532-2) / 10 mL in 1 VIAL, SINGLE-DOSE

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": "1035853c-6cb9-76b2-e063-6394a90a3938", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["c53e2b38-6c49-acae-e053-2995a90ae9df"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 VIAL, SINGLE-DOSE (51662-1532-1)", "package_ndc": "51662-1532-1", "marketing_start_date": "20210620"}, {"sample": false, "description": "10 POUCH in 1 CASE (51662-1532-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1532-2)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "51662-1532-3", "marketing_start_date": "20210620"}], "brand_name": "TRANEXAMIC ACID", "product_id": "51662-1532_1035853c-6cb9-76b2-e063-6394a90a3938", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "51662-1532", "generic_name": "TRANEXAMIC ACID", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRANEXAMIC ACID", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "100 mg/mL"}], "application_number": "ANDA205035", "marketing_category": "ANDA", "marketing_start_date": "20210620", "listing_expiration_date": "20261231"}