Application 040084

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	750MG;7.5MG	No	No
002	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	500MG;5MG	No	No
003	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	660MG;10MG	No	No
004	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	ACETAMINOPHEN; HYDROCODONE BITARTRATE	TABLET;ORAL	650MG;10MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42254-223	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Rebel Distributors Corp	ANDA	Current
42254-244	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	Rebel Distributors Corp	ANDA	Current