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Potassium Chloride

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

Approved
Approval ID

142c30ff-a839-4616-8167-ad4b07d8456f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 10, 2022

Manufacturers
FDA

VistaPharm, Inc.

DUNS: 116743084

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 Code66689-048
Application NumberNDA206814
Product Classification
M
Marketing Category
C73594
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2022
FDA Product Classification

INGREDIENTS (8)

POTASSIUM CHLORIDEActive
Quantity: 40 meq in 30 mL
Code: 660YQ98I10
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT

Potassium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code66689-047
Application NumberNDA206814
Product Classification
M
Marketing Category
C73594
G
Generic Name
Potassium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2022
FDA Product Classification

INGREDIENTS (8)

FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
POTASSIUM CHLORIDEActive
Quantity: 20 meq in 15 mL
Code: 660YQ98I10
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT

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Potassium Chloride - FDA Drug Approval Details