tranexamic acid

Generic: tranexamic acid

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

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

tranexamic acid 650 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3720
Product ID 0591-3720_b97d11de-dcc7-4b90-8f6a-c46848eddab3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202093
Listing Expiration 2027-12-31
Marketing Start 2013-01-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05913720
Hyphenated Format 0591-3720

Supplemental Identifiers

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 ANDA202093 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3720-30)
source: ndc

Packages (1)

0591-3720-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3720-30)

Ingredients (1)

tranexamic acid (650 mg/1)

Linked Drug Pages (1)

Tranexamic Acid ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b97d11de-dcc7-4b90-8f6a-c46848eddab3", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "spl_set_id": ["3f07e93b-3568-487e-894f-8f90e5a0960a"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0591-3720-30)", "package_ndc": "0591-3720-30", "marketing_start_date": "20130103"}], "brand_name": "Tranexamic Acid", "product_id": "0591-3720_b97d11de-dcc7-4b90-8f6a-c46848eddab3", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "0591-3720", "generic_name": "Tranexamic Acid", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tranexamic Acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "650 mg/1"}], "application_number": "ANDA202093", "marketing_category": "ANDA", "marketing_start_date": "20130103", "listing_expiration_date": "20271231"}