Sodium Citrate and Citric Acid
Sodium Citrate and Citric Acid Oral Solution, USP
Approved
Approval ID
525136c9-7758-437b-b57b-94b905786825
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
Products 1
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-434
Product Classification
G
Generic Name
Sodium Citrate and Citric Acid
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (6)
CITRIC ACID MONOHYDRATEActive
Quantity: 334 mg in 5 mL
Code: 2968PHW8QP
Classification: ACTIM
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATEActive
Quantity: 500 mg in 5 mL
Code: 1Q73Q2JULR
Classification: ACTIB