Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Promethazine VC With Codeine
Product Details
NDC Product Code
54868-0263Application Number
ANDA040660Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 9, 2011WATERInactive
Code: 059QF0KO0RClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
PhenylephrineActive
Code: 04JA59TNSJClass: ACTIBQuantity: 5 mg in 5 mL
PromethazineActive
Code: R61ZEH7I1IClass: ACTIBQuantity: 6.25 mg in 5 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
CodeineActive
Code: GSL05Y1MN6Class: ACTIBQuantity: 10 mg in 5 mL
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0LClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
MENTHOLInactive
Code: L7T10EIP3AClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT