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
0cdf3f67-5bf3-4d58-b330-03febdc652bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 18, 2020
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 2
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 Code0143-9559
Application NumberNDA203049
Product Classification
M
Marketing Category
C73594
G
Generic Name
Argatroban
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 18, 2020
FDA Product Classification
INGREDIENTS (4)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ARGATROBANActive
Quantity: 50 mg in 50 mL
Code: IY90U61Z3S
Classification: ACTIM
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
Argatroban
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9674
Application NumberNDA203049
Product Classification
M
Marketing Category
C73594
G
Generic Name
Argatroban
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 18, 2020
FDA Product Classification
INGREDIENTS (3)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ARGATROBANActive
Quantity: 250 mg in 2.5 mL
Code: IY90U61Z3S
Classification: ACTIM
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT