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Potassium Acetate

POTASSIUM ACETATE INJECTION, USP

Approved
Approval ID

d5f6dc05-9fb0-4a89-8c54-46112df10abd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 15, 2019

Manufacturers
FDA

Exela Pharma Sciences, LLC

DUNS: 831274399

Products 2

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

Potassium Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51754-2005
Application NumberANDA212692
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Acetate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 15, 2019
FDA Product Classification

INGREDIENTS (2)

ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
POTASSIUM ACETATEActive
Quantity: 100 meq in 50 mL
Code: M911911U02
Classification: ACTIB

Potassium Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code51754-2004
Application NumberANDA206203
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Acetate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 15, 2019
FDA Product Classification

INGREDIENTS (2)

POTASSIUM ACETATEActive
Quantity: 200 meq in 100 mL
Code: M911911U02
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT

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Potassium Acetate - FDA Drug Approval Details