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sodium nitroprusside in 0.9% sodium chloride

These highlights do not include all the information needed to use SODIUM NITROPRUSSIDE in 0.9% SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for SODIUM NITROPRUSSIDE in 0.9% SODIUM CHLORIDE INJECTION. SODIUM NITROPRUSSIDE in SODIUM CHLORIDE injection, for intravenous use Initial U.S. Approval: 1988

Approved
Approval ID

6f02e4ac-5f7c-4003-b9b7-283f489cddb0

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 15, 2023

Manufacturers
FDA

Slate Run Pharmaceuticals, LLC

DUNS: 039452765

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

sodium nitroprusside in 0.9% sodium chloride

PRODUCT DETAILS

NDC Product Code70436-207
Application NumberANDA215846
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateNovember 15, 2023
Generic Namesodium nitroprusside in 0.9% sodium chloride

INGREDIENTS (3)

SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM NITROPRUSSIDEActive
Quantity: 0.5 mg in 1 mL
Code: EAO03PE1TC
Classification: ACTIB

sodium nitroprusside in 0.9% sodium chloride

PRODUCT DETAILS

NDC Product Code70436-206
Application NumberANDA215846
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateNovember 15, 2023
Generic Namesodium nitroprusside in 0.9% sodium chloride

INGREDIENTS (3)

SODIUM CHLORIDEInactive
Quantity: 9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM NITROPRUSSIDEActive
Quantity: 0.2 mg in 1 mL
Code: EAO03PE1TC
Classification: ACTIB

sodium nitroprusside in 0.9% sodium chloride

PRODUCT DETAILS

NDC Product Code70436-205
Application NumberANDA215846
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateNovember 15, 2023
Generic Namesodium nitroprusside in 0.9% sodium chloride

INGREDIENTS (3)

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
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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sodium nitroprusside in 0.9% sodium chloride - FDA Drug Approval Details