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Sodium Nitroprusside

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

72a9b7df-3a2f-4c16-93a9-b645bc0e8143

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 31, 2022

Manufacturers
FDA

Hainan Poly Pharm. Co., Ltd.

DUNS: 654561638

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 Code14335-134
Application NumberANDA215846
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Nitroprusside
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2022
FDA Product Classification

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14335-132
Application NumberANDA215846
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Nitroprusside
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2022
FDA Product Classification

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14335-133
Application NumberANDA215846
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sodium Nitroprusside
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2022
FDA Product Classification

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

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