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Potassium Chloride

These highlights do not include all the information needed to use safely and effectively. See full prescribing information for .  Initial U.S. Approval: 1948

Approved
Approval ID

b917235f-7989-4570-9532-fc5ff0468784

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 23, 2019

Manufacturers
FDA

DOH CENTRAL PHARMACY

DUNS: 829348114

Products 1

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 Code53808-1125
Application NumberANDA204662
Product Classification
M
Marketing Category
C73584
G
Generic Name
potassium chloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2019
FDA Product Classification

INGREDIENTS (10)

POTASSIUM CHLORIDEActive
Quantity: 10 meq in 1 1
Code: 660YQ98I10
Classification: ACTIB
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT

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Potassium Chloride - FDA Drug Approval Details