Sodium Citrate and Citric Acid
Sodium Citrate and Citric Acid Oral Solution USP
Approved
Approval ID
fe070e2e-3e72-fb84-e053-6294a90afd88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 13, 2023
Manufacturers
FDA
AvPAK
DUNS: 832926666
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-182
Product Classification
G
Generic Name
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 13, 2023
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS CITRIC ACIDActive
Quantity: 334 mg in 5 mL
Code: XF417D3PSL
Classification: ACTIB
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM CITRATEActive
Quantity: 500 mg in 5 mL
Code: 1Q73Q2JULR
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-183
Product Classification
G
Generic Name
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 13, 2023
FDA Product Classification
INGREDIENTS (6)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATEActive
Quantity: 500 mg in 5 mL
Code: 1Q73Q2JULR
Classification: ACTIB
ANHYDROUS CITRIC ACIDActive
Quantity: 334 mg in 5 mL
Code: XF417D3PSL
Classification: ACTIB
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT