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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

1a839f91-9bbd-4f46-b350-c5e8074b5db7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 3, 2023

Manufacturers
FDA

Zydus Pharmaceuticals (USA) Inc.

DUNS: 156861945

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 Code68382-537
Application NumberANDA203546
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification

INGREDIENTS (3)

POTASSIUM CITRATEActive
Quantity: 10 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
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 Code68382-538
Application NumberANDA203546
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification

INGREDIENTS (3)

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

Potassium Citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68382-536
Application NumberANDA203546
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Citrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification

INGREDIENTS (3)

POTASSIUM CITRATEActive
Quantity: 5 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