Label: TRANEXAMIC ACID injection, solution
- NDC Code(s): 14593-318-01
- Packager: Emcure Pharmaceuticals Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 28, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- INDICATIONS AND USAGE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TRANEXAMIC ACID
tranexamic acid injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:14593-318 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRANEXAMIC ACID (UNII: 6T84R30KC1) (TRANEXAMIC ACID - UNII:6T84R30KC1) TRANEXAMIC ACID 1 g in 10 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:14593-318-01 10 in 1 CARTON 10/28/2024 1 10 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA203521 10/28/2024 Labeler - Emcure Pharmaceuticals Limited (916921919) Registrant - Emcure Pharmaceuticals Limited (916921919) Establishment Name Address ID/FEI Business Operations Emcure Pharmaceuticals Limited 675467924 ANALYSIS(14593-318) , MANUFACTURE(14593-318) , PACK(14593-318) , LABEL(14593-318)