tranexamic acid in sodium chloride

Generic: tranexamic acid

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

Drug Facts

Product Profile

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

tranexamic acid 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-613
Product ID 68083-613_71e0764f-b584-49fb-ba62-11f3fb32d3fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218599
Listing Expiration 2026-12-31
Marketing Start 2024-04-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083613
Hyphenated Format 68083-613

Supplemental Identifiers

RxCUI
2170286
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 in sodium chloride (source: ndc)
Generic Name tranexamic acid (source: ndc)
Application Number ANDA218599 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (68083-613-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
source: ndc

Packages (1)

68083-613-10 10 POUCH in 1 CARTON (68083-613-10) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

Ingredients (1)

tranexamic acid (10 mg/mL)

Linked Drug Pages (1)

TRANEXAMIC ACID IN SODIUM CHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "71e0764f-b584-49fb-ba62-11f3fb32d3fc", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["2170286"], "spl_set_id": ["f06f07de-bedf-4b37-b15e-0959e0a154e6"], "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 POUCH in 1 CARTON (68083-613-10)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "68083-613-10", "marketing_start_date": "20240416"}], "brand_name": "TRANEXAMIC ACID IN SODIUM CHLORIDE", "product_id": "68083-613_71e0764f-b584-49fb-ba62-11f3fb32d3fc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "68083-613", "generic_name": "TRANEXAMIC ACID", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRANEXAMIC ACID IN SODIUM CHLORIDE", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "10 mg/mL"}], "application_number": "ANDA218599", "marketing_category": "ANDA", "marketing_start_date": "20240416", "listing_expiration_date": "20261231"}