MedPath
FDA Approval

Sodium Citrate and Citric Acid

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

FDA Approval Summary

Company
Chartwell RX, LLC
DUNS: 079394054
Effective Date
October 5, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
VS-01(334 mg in 5 mL)
Sodium citrate(500 mg in 5 mL)

Manufacturing Establishments1

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

Chartwell Pharmaceuticals Carmel, LLC

Chartwell RX, LLC

118673485

Products1

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

Sodium Citrate and Citric Acid

Product Details

NDC Product Code
62135-434
Route of Administration
ORAL
Effective Date
October 5, 2023
VS-01Active
Code: 2968PHW8QPClass: ACTIMQuantity: 334 mg in 5 mL
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
Code: 1Q73Q2JULRClass: ACTIBQuantity: 500 mg in 5 mL
© Copyright 2025. All Rights Reserved by MedPath