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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-229
Application NumberANDA089454
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROTAMINE SULFATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 17, 2023
FDA Product Classification
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