Sodium Nitrite
These highlights do not include all the information needed to use Sodium Nitrite Injection safely and effectively. See full prescribing information for Sodium Nitrite Injection. Sodium Nitrite Injection, USPInitial U.S. Approval: 2011
Approved
Approval ID
52f01c6e-172a-47a9-98a6-9eab7651a032
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2022
Manufacturers
FDA
Hope Pharmaceuticals
DUNS: 015227945
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Nitrite
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60267-311
Application NumberNDA203922
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium Nitrite
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 20, 2021
FDA Product Classification
INGREDIENTS (3)
Sodium NitriteActive
Quantity: 30 mg in 1 mL
Code: M0KG633D4F
Classification: ACTIB
WaterInactive
Code: 059QF0KO0R
Classification: IACT
NitrogenInactive
Code: N762921K75
Classification: IACT