tranexamic acid in sodium chloride

Generic: tranexamic acid

Labeler: exela pharma sciences, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid in sodium chloride
Generic Name tranexamic acid
Labeler exela pharma sciences, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 10 mg/mL

Manufacturer
Exela Pharma Sciences, LLC

Identifiers & Regulatory

Product NDC 51754-0108
Product ID 51754-0108_0ae0a575-08e1-43a3-9b6c-8c5f165db35f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212020
Listing Expiration 2026-12-31
Marketing Start 2019-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 517540108
Hyphenated Format 51754-0108

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 NDA212020 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 100 mL in 1 BAG (51754-0108-1)
  • 1000 mL in 1 CASE (51754-0108-3)
source: ndc

Packages (2)

51754-0108-1 100 mL in 1 BAG (51754-0108-1) 51754-0108-3 1000 mL in 1 CASE (51754-0108-3)

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": "0ae0a575-08e1-43a3-9b6c-8c5f165db35f", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["2170286"], "spl_set_id": ["db36ddf2-4ac5-47ac-bdce-e3fa6983073e"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Exela Pharma Sciences, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BAG (51754-0108-1)", "package_ndc": "51754-0108-1", "marketing_start_date": "20190601"}, {"sample": false, "description": "1000 mL in 1 CASE (51754-0108-3)", "package_ndc": "51754-0108-3", "marketing_start_date": "20190601"}], "brand_name": "TRANEXAMIC ACID IN SODIUM CHLORIDE", "product_id": "51754-0108_0ae0a575-08e1-43a3-9b6c-8c5f165db35f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "51754-0108", "generic_name": "tranexamic acid", "labeler_name": "Exela Pharma Sciences, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TRANEXAMIC ACID IN SODIUM CHLORIDE", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "10 mg/mL"}], "application_number": "NDA212020", "marketing_category": "NDA", "marketing_start_date": "20190601", "listing_expiration_date": "20261231"}