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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

360a1012-4bdb-473a-8f1f-4550d3b51343

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 21, 2022

Manufacturers
FDA

XLCare Pharmaceuticals, Inc.

DUNS: 080991142

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 Code72865-191
Application NumberANDA214420
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification

INGREDIENTS (4)

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

Potassium Citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72865-192
Application NumberANDA214420
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification

INGREDIENTS (4)

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

Potassium Citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72865-193
Application NumberANDA214420
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification

INGREDIENTS (4)

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

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