tranexamic acid

Generic: tranexamic acid

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid
Generic Name tranexamic acid
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 100 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-160
Product ID 68083-160_3756c37f-5de9-49d4-a756-89cbd5c237e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207239
Listing Expiration 2026-12-31
Marketing Start 2017-02-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083160
Hyphenated Format 68083-160

Supplemental Identifiers

RxCUI
238720
UPC
0368083160104
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 ANDA207239 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-160-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

68083-160-10 10 VIAL in 1 CARTON (68083-160-10) / 10 mL in 1 VIAL

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": "3756c37f-5de9-49d4-a756-89cbd5c237e7", "openfda": {"nui": ["N0000175634", "N0000175632"], "upc": ["0368083160104"], "unii": ["6T84R30KC1"], "rxcui": ["238720"], "spl_set_id": ["31462875-4941-4d50-bf0c-9675493731f3"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-160-10)  / 10 mL in 1 VIAL", "package_ndc": "68083-160-10", "marketing_start_date": "20170222"}], "brand_name": "Tranexamic acid", "product_id": "68083-160_3756c37f-5de9-49d4-a756-89cbd5c237e7", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "68083-160", "generic_name": "Tranexamic acid", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tranexamic acid", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "100 mg/mL"}], "application_number": "ANDA207239", "marketing_category": "ANDA", "marketing_start_date": "20170222", "listing_expiration_date": "20261231"}