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Potassium Chloride for Oral Solution

These highlights do not include all the information needed to use POTASSIUM CHLORIDE FOR ORAL SOLUTION safely and effectively. See full prescribing information for POTASSIUM CHLORIDE FOR ORAL SOLUTION. POTASSIUM CHLORIDE for oral solution Initial U.S. Approval: 1948

Approved
Approval ID

1ea4345e-f8bb-4d41-9003-c87b21169d7c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 5, 2023

Manufacturers
FDA

BPI Labs LLC

DUNS: 078627620

Products 1

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

Potassium Chloride for Oral Solution

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54288-125
Application NumberANDA212183
Product Classification
M
Marketing Category
C73584
G
Generic Name
Potassium Chloride for Oral Solution
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification

INGREDIENTS (6)

ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 1.5 g in 1.58 g
Code: 660YQ98I10
Classification: ACTIB

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Potassium Chloride for Oral Solution - FDA Drug Approval Details