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 only Initial U.S. Approval: 2000
Approved
Approval ID
990b046f-bfd8-496c-ac58-8c7d79257c5c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2022
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
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 Code0409-1140
Application NumberANDA204120
Product Classification
M
Marketing Category
C73584
G
Generic Name
Argatroban
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 15, 2019
FDA Product Classification
INGREDIENTS (3)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ARGATROBANActive
Quantity: 100 mg in 1 mL
Code: IY90U61Z3S
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT