SODIUM ACETATE
SODIUM ACETATE Injection, USP
Approved
Approval ID
dfa26fd6-53dd-499c-8c40-fd0623d2c8f1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Woodward Pharma Services LLC
DUNS: 080406260
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69784-232
Application NumberANDA214805
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM ACETATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (3)
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM ACETATEActive
Quantity: 328 mg in 1 mL
Code: 4550K0SC9B
Classification: ACTIR
SODIUM ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69784-230
Application NumberANDA214805
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM ACETATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (3)
SODIUM ACETATEActive
Quantity: 164 mg in 1 mL
Code: 4550K0SC9B
Classification: ACTIR
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69784-231
Application NumberANDA214805
Product Classification
M
Marketing Category
C73584
G
Generic Name
SODIUM ACETATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (3)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEActive
Quantity: 164 mg in 1 mL
Code: 4550K0SC9B
Classification: ACTIR