Protamine Sulfate
Protamine Sulfate Injection, USP
Approved
Approval ID
e1964129-33f4-4e4e-86e3-8e6a4e65bd83
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 17, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PROTAMINE SULFATE
PRODUCT DETAILS
NDC Product Code63323-229
Application NumberANDA089454
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateMarch 17, 2023
Generic NamePROTAMINE SULFATE
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
PROTAMINE SULFATEActive
Quantity: 10 mg in 1 mL
Code: 0DE9724IHC
Classification: ACTIB