tranexamic acid

Generic: tranexamic acid

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 100 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-563
Product ID 63323-563_ddb5d068-9d9e-45da-92d7-516dd792af1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091596
Listing Expiration 2026-12-31
Marketing Start 2012-05-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323563
Hyphenated Format 63323-563

Supplemental Identifiers

RxCUI
238720
UPC
0363323563011
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 ANDA091596 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 TRAY (63323-563-10) / 10 mL in 1 VIAL (63323-563-01)
source: ndc

Packages (1)

63323-563-10 10 VIAL in 1 TRAY (63323-563-10) / 10 mL in 1 VIAL (63323-563-01)

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": "ddb5d068-9d9e-45da-92d7-516dd792af1b", "openfda": {"nui": ["N0000175634", "N0000175632"], "upc": ["0363323563011"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["c6c3da51-fc45-4d5c-b983-1576830c95dd"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (63323-563-10)  / 10 mL in 1 VIAL (63323-563-01)", "package_ndc": "63323-563-10", "marketing_start_date": "20120524"}], "brand_name": "Tranexamic Acid", "product_id": "63323-563_ddb5d068-9d9e-45da-92d7-516dd792af1b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "63323-563", "generic_name": "Tranexamic Acid", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tranexamic Acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "100 mg/mL"}], "application_number": "ANDA091596", "marketing_category": "ANDA", "marketing_start_date": "20120524", "listing_expiration_date": "20261231"}