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FDA Approval

Potassium Chloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
October 5, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Potassium chloride(20 meq in 15 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Belcher Pharmaceuticals LLC

Belcher Pharmaceuticals LLC

965082543

Products2

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

Potassium Chloride

Product Details

NDC Product Code
62250-713
Application Number
ANDA216156
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 5, 2023
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
Code: 660YQ98I10Class: ACTIBQuantity: 20 meq in 15 mL

Potassium Chloride

Product Details

NDC Product Code
62250-714
Application Number
ANDA216156
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
October 5, 2023
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: 660YQ98I10Class: ACTIBQuantity: 40 meq in 15 mL
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
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