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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 useInitial U.S. Approval: 1985

Approved
Approval ID

5f38b02c-703c-4fc2-b833-654e41bd617f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 25, 2023

Manufacturers
FDA

Strides Pharma Inc.

DUNS: 078310501

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 Code42543-406
Application NumberANDA206813
Product Classification
M
Marketing Category
C73584
G
Generic Name
POTASSIUM CITRATE
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2023
FDA Product Classification

INGREDIENTS (4)

POTASSIUM CITRATEActive
Quantity: 5 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
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 Code42543-407
Application NumberANDA206813
Product Classification
M
Marketing Category
C73584
G
Generic Name
POTASSIUM CITRATE
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2023
FDA Product Classification

INGREDIENTS (4)

CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM CITRATEActive
Quantity: 10 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT

POTASSIUM CITRATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42543-408
Application NumberANDA206813
Product Classification
M
Marketing Category
C73584
G
Generic Name
POTASSIUM CITRATE
Product Specifications
Route of AdministrationORAL
Effective DateMay 25, 2023
FDA Product Classification

INGREDIENTS (4)

MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POTASSIUM CITRATEActive
Quantity: 15 meq in 1 1
Code: EE90ONI6FF
Classification: ACTIB

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