Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rebel Distributors Corp
Rebel Distributors Corp
118802834
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Promethazine with Codeine
Product Details
NDC Product Code
21695-336Application Number
ANDA040650Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 27, 2009PromethazineActive
Code: R61ZEH7I1IClass: ACTIBQuantity: 6.25 mg in 5 mL
CodeineActive
Code: GSL05Y1MN6Class: ACTIBQuantity: 10 mg in 5 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQYClass: IACT
MENTHOLInactive
Code: L7T10EIP3AClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT