Application 020232

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FIORICET W/ CODEINE	ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE	CAPSULE;ORAL	325MG;50MG;40MG;30MG	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3220	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3220	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3220	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3220	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3220	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
63629-3152	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-3152	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-3152	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current