Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pharmaceutical Associates, Inc.
Pharmaceutical Associates, Inc.
097630693
Products2
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
0121-1190Route of Administration
ORALEffective Date
December 15, 2022SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
Sodium citrateActive
Code: 1Q73Q2JULRClass: ACTIBQuantity: 500 mg in 5 mL
Citric acidActive
Code: XF417D3PSLClass: ACTIBQuantity: 334 mg in 5 mL
Sodium Citrate and Citric Acid
Product Details
NDC Product Code
0121-0595Route of Administration
ORALEffective Date
December 15, 2022POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
Sodium citrateActive
Code: 1Q73Q2JULRClass: ACTIBQuantity: 500 mg in 5 mL
Citric acidActive
Code: XF417D3PSLClass: ACTIBQuantity: 334 mg in 5 mL