tranexamic acid

Generic: tranexamic acid

Labeler: micro labs limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler micro labs limited
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 100 mg/mL

Manufacturer
Micro Labs Limited

Identifiers & Regulatory

Product NDC 42571-314
Product ID 42571-314_45fc1537-9ab6-d1e9-e063-6394a90ab620
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206713
Listing Expiration 2026-12-31
Marketing Start 2017-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42571314
Hyphenated Format 42571-314

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 ANDA206713 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 CARTON in 1 CARTON (42571-314-89) / 1 VIAL, GLASS in 1 CARTON (42571-314-88) / 10 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

42571-314-89 10 CARTON in 1 CARTON (42571-314-89) / 1 VIAL, GLASS in 1 CARTON (42571-314-88) / 10 mL in 1 VIAL, GLASS

Ingredients (1)

tranexamic acid (100 mg/mL)

Linked Drug Pages (1)

Tranexamic Acid, TRANEXAMIC ACID ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "45fc1537-9ab6-d1e9-e063-6394a90ab620", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["ee5aeb09-40fb-40f9-b655-97c50652a05e"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Micro Labs Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CARTON in 1 CARTON (42571-314-89)  / 1 VIAL, GLASS in 1 CARTON (42571-314-88)  / 10 mL in 1 VIAL, GLASS", "package_ndc": "42571-314-89", "marketing_start_date": "20170801"}], "brand_name": "TRANEXAMIC ACID", "product_id": "42571-314_45fc1537-9ab6-d1e9-e063-6394a90ab620", "dosage_form": "INJECTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "42571-314", "generic_name": "TRANEXAMIC ACID", "labeler_name": "Micro Labs Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRANEXAMIC ACID", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "100 mg/mL"}], "application_number": "ANDA206713", "marketing_category": "ANDA", "marketing_start_date": "20170801", "listing_expiration_date": "20261231"}