ARGATROBAN
These highlights do not include all the information needed to use ARGATROBAN IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for ARGATROBAN IN SODIUM CHLORIDE INJECTION. ARGATROBAN IN SODIUM CHLORIDE Injection, for intravenous use Initial U.S. Approval: 2000
Approved
Approval ID
46cdf9e6-839c-49c8-9ee1-c30cfdd9368d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2022
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Argatroban
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16729-430
Application NumberNDA212035
Product Classification
M
Marketing Category
C73594
G
Generic Name
Argatroban
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 7, 2022
FDA Product Classification
INGREDIENTS (3)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SORBITOLInactive
Quantity: 3 mg in 1 mL
Code: 506T60A25R
Classification: IACT
ARGATROBANActive
Quantity: 1 mg in 1 mL
Code: IY90U61Z3S
Classification: ACTIB