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POTASSIUM CITRATE

These highlights do not include all the information needed to use POTASSIUM CITRATE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for POTASSIUM CITRATE EXTENDED-RELEASE TABLETS. POTASSIUM CITRATE extended-release tablets, for oral use Initial U.S. Approval: 1985

Approved
Approval ID

e49f812c-74e2-4ee7-80d8-57f7f93fe02b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2021

Manufacturers
FDA

Ascent Pharmaceuticals Inc

DUNS: 080938961

Products 3

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

Potassium Citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43602-401
Application NumberANDA214420
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2021
FDA Product Classification

INGREDIENTS (4)

POTASSIUM CITRATEActive
Quantity: 15 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

Potassium Citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43602-399
Application NumberANDA214420
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2021
FDA Product Classification

INGREDIENTS (4)

POTASSIUM CITRATEActive
Quantity: 5 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

Potassium Citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43602-400
Application NumberANDA214420
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2021
FDA Product Classification

INGREDIENTS (4)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POTASSIUM CITRATEActive
Quantity: 10 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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POTASSIUM CITRATE - FDA Drug Approval Details