PROTAMINE SULFATE
PROTAMINE SULFATE INJECTION, USP 50mg/5mL (10mg/mL) 5mL VIAL
Approved
Approval ID
94d4f57f-940e-c0a8-e053-2a95a90ae3af
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2024
Manufacturers
FDA
HF Acquisition Co LLC, DBA HealthFirst
DUNS: 045657305
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 Code51662-1414
Application NumberANDA089454
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateJanuary 22, 2024
Generic NamePROTAMINE SULFATE
INGREDIENTS (4)
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
PROTAMINE SULFATEActive
Quantity: 10 mg in 1 mL
Code: 0DE9724IHC
Classification: ACTIB
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT