ARGATROBAN
These highlights do not include all the information needed to use ARGATROBAN INJECTION safely and effectively. See full prescribing information for ARGATROBAN INJECTION. ARGATROBAN Injection, for intravenous use Initial U.S. Approval: 2000
Approved
Approval ID
b5143563-ff45-433a-a9e2-f8b8340db1f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2021
Manufacturers
FDA
Caplin Steriles Limited
DUNS: 650744670
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 Code65145-126
Application NumberANDA214235
Product Classification
M
Marketing Category
C73584
G
Generic Name
Argatroban
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 1, 2021
FDA Product Classification
INGREDIENTS (4)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
ARGATROBANActive
Quantity: 50 mg in 50 mL
Code: IY90U61Z3S
Classification: ACTIM
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT