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 infusion onlyInitial U.S. Approval: 2000
Approved
Approval ID
1a67a87d-59cb-414c-a11e-ab8f0a9bb778
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 31, 2018
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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 Code42023-182
Application NumberANDA091665
Product Classification
M
Marketing Category
C73584
G
Generic Name
Argatroban
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateFebruary 9, 2023
FDA Product Classification
INGREDIENTS (3)
ARGATROBANActive
Quantity: 250 mg in 2.5 mL
Code: IY90U61Z3S
Classification: ACTIM
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT