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.
Hydrocodone Bitartrate and Acetaminophen
Product Details
NDC Product Code
21695-816Application Number
ANDA040182Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
April 24, 2009HydrocodoneActive
Code: NO70W886KKClass: ACTIBQuantity: 2.5 mg in 5 mL
AcetaminophenActive
Code: 362O9ITL9DClass: ACTIBQuantity: 167 mg in 5 mL
AlcoholInactive
Code: 3K9958V90MClass: IACT
Citric AcidInactive
Code: 2968PHW8QPClass: IACT
GlycerinInactive
Code: PDC6A3C0OXClass: IACT
Saccharin SodiumInactive
Code: SB8ZUX40TYClass: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3Class: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
SorbitolInactive
Code: 506T60A25RClass: IACT
SucroseInactive
Code: C151H8M554Class: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3GClass: IACT
MethylparabenInactive
Code: A2I8C7HI9TClass: IACT