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
62135-434Route of Administration
ORALEffective Date
October 5, 2023VS-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
Sodium citrateActive
Code: 1Q73Q2JULRClass: ACTIBQuantity: 500 mg in 5 mL