NIPRIDE RTU
These highlights do not include all the information needed to use NIPRIDE RTU safely and effectively. See full prescribing information for NIPRIDE RTU. NIPRIDE RTU, for intravenous useInitial U.S. Approval: 1988
Approved
Approval ID
5acf0836-93ff-4064-b888-3f560e8a558d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2018
Manufacturers
FDA
EXELA PHARMA SCIENCES, LLC
DUNS: 831274399
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Nitroprusside
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-1029
Application NumberNDA209387
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium Nitroprusside
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 20, 2018
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM NITROPRUSSIDEActive
Quantity: 0.2 mg in 1 mL
Code: EAO03PE1TC
Classification: ACTIB
Sodium Nitroprusside
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-1006
Application NumberNDA209387
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium Nitroprusside
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 20, 2018
FDA Product Classification
INGREDIENTS (3)
SODIUM NITROPRUSSIDEActive
Quantity: 0.5 mg in 1 mL
Code: EAO03PE1TC
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 900 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Sodium Nitroprusside
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-1018
Application NumberNDA209387
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium Nitroprusside
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 20, 2018
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM NITROPRUSSIDEActive
Quantity: 0.2 mg in 1 mL
Code: EAO03PE1TC
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT