Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release
Product Details
NDC Product Code
27808-086Application Number
ANDA091632Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 31, 2021ChlorpheniramineActive
Code: V1Q0O9OJ9ZClass: ACTIBQuantity: 8 mg in 5 mL
HydrocodoneActive
Code: NO70W886KKClass: ACTIBQuantity: 10 mg in 5 mL
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6SClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POLYVINYL ACETATEInactive
Code: 32K497ZK2UClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
SODIUM METABISULFITEInactive
Code: 4VON5FNS3CClass: IACT
SODIUM POLYSTYRENE SULFONATEInactive
Code: 1699G8679ZClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TRIACETINInactive
Code: XHX3C3X673Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT