Sodium Thiosulfate
These highlights do not include all the information needed to use the SODIUM THIOSULFATE INJECTION safely and effectively. See full prescribing information for SODIUM THIOSULFATE INJECTION. Sodium Thiosulfate Injection, USP Initial U.S. Approval: 1992
Approved
Approval ID
82f55408-2de9-463d-85e8-b39c3b259f0b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2023
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 Thiosulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60267-705
Application NumberNDA203923
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sodium Thiosulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 16, 2023
FDA Product Classification
INGREDIENTS (6)
Sodium ThiosulfateActive
Quantity: 250 mg in 1 mL
Code: HX1032V43M
Classification: ACTIB
NitrogenInactive
Code: N762921K75
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Boric AcidInactive
Quantity: 2.8 mg in 1 mL
Code: R57ZHV85D4
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Potassium ChlorideInactive
Quantity: 4.4 mg in 1 mL
Code: 660YQ98I10
Classification: IACT