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Potassium Chloride

POTASSIUM CHLORIDE EXTENDED-RELEASE TABLETS, USP

Approved
Approval ID

15144260-ae88-45a0-a940-0e2f7b63e8ca

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 5, 2012

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 2

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

Potassium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-3671
Application NumberANDA075604
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 5, 2012
FDA Product Classification

INGREDIENTS (5)

POTASSIUM CHLORIDEActive
Quantity: 10 meq in 1 1
Code: 660YQ98I10
Classification: ACTIM
ACETYLTRIBUTYL CITRATEInactive
Code: 0ZBX0N59RZ
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

Potassium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-4617
Application NumberANDA075604
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 5, 2012
FDA Product Classification

INGREDIENTS (5)

ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 20 meq in 1 1
Code: 660YQ98I10
Classification: ACTIM
ACETYLTRIBUTYL CITRATEInactive
Code: 0ZBX0N59RZ
Classification: IACT

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Potassium Chloride - FDA Drug Approval Details