Sodium Citrate and Citric Acid
Sodium Citrate and Citric Acid Oral Solution USP
Approved
Approval ID
63201a61-6ac5-41ae-8b2d-ff0d3a8ddfd5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2022
Manufacturers
FDA
Pharmaceutical Associates, Inc.
DUNS: 044940096
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 Code0121-1190
Product Classification
G
Generic Name
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2022
FDA Product Classification
INGREDIENTS (7)
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
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
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0121-0595
Product Classification
G
Generic Name
SODIUM CITRATE and CITRIC ACID MONOHYDRATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2022
FDA Product Classification
INGREDIENTS (7)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
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