tranexamic acid in sodium chloride

Generic: tranexamic acid

Labeler: avenacy inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tranexamic acid in sodium chloride
Generic Name tranexamic acid
Labeler avenacy inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tranexamic acid 10 mg/mL

Manufacturer
Avenacy Inc.

Identifiers & Regulatory

Product NDC 83634-403
Product ID 83634-403_3de7c58b-1244-4ba9-af17-7a7f318e1255
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218896
Listing Expiration 2026-12-31
Marketing Start 2025-09-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83634403
Hyphenated Format 83634-403

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 ANDA218896 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-403-51) / 100 mL in 1 VIAL, SINGLE-DOSE (83634-403-82)
source: ndc

Packages (1)

83634-403-51 10 VIAL, SINGLE-DOSE in 1 CARTON (83634-403-51) / 100 mL in 1 VIAL, SINGLE-DOSE (83634-403-82)

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": "3de7c58b-1244-4ba9-af17-7a7f318e1255", "openfda": {"nui": ["N0000175634", "N0000175632"], "unii": ["6T84R30KC1"], "rxcui": ["2170286"], "spl_set_id": ["c3aad84a-aa99-42a0-b4b6-6fdee7585e19"], "pharm_class_pe": ["Decreased Fibrinolysis [PE]"], "pharm_class_epc": ["Antifibrinolytic Agent [EPC]"], "manufacturer_name": ["Avenacy Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (83634-403-51)  / 100 mL in 1 VIAL, SINGLE-DOSE (83634-403-82)", "package_ndc": "83634-403-51", "marketing_start_date": "20250901"}], "brand_name": "tranexamic acid in sodium chloride", "product_id": "83634-403_3de7c58b-1244-4ba9-af17-7a7f318e1255", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Antifibrinolytic Agent [EPC]", "Decreased Fibrinolysis [PE]"], "product_ndc": "83634-403", "generic_name": "tranexamic acid", "labeler_name": "Avenacy Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "tranexamic acid in sodium chloride", "active_ingredients": [{"name": "TRANEXAMIC ACID", "strength": "10 mg/mL"}], "application_number": "ANDA218896", "marketing_category": "ANDA", "marketing_start_date": "20250901", "listing_expiration_date": "20261231"}