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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51662-1414
Application NumberANDA089454
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROTAMINE SULFATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 22, 2024
FDA Product Classification
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