Zebutal

Product NDC: 68308-554
11-digit product format: 683080554
Labeler code: 68308
Product ID: 68308-554_ea23bc04-96ae-45e8-e053-2a95a90acd45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital, acetaminophen and caffeine
Dosage form: CAPSULE
Route: ORAL
Labeler: Mayne Pharma Inc.
Application: ANDA089007
Marketing category: ANDA
Marketing start: 2013-12-26
Marketing end: 2023-10-31
Substance: ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength: 325 mg/1; mg/1; mg/1
Pharmacologic classes: Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68308-554-10	EA - Each	68308-554	73e70e70-ba1a-4315-8db9-501a79cd1184	1	2014-02-04

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
KHS0AZ4JVK	BUTALBITAL	77-26-9	BUTALBITAL
3G6A5W338E	CAFFEINE	58-08-2	CAFFEINE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68308-554-10	68308055410	100 CAPSULE in 1 BOTTLE, PLASTIC (68308-554-10)	100 capsule	2013-12-26	0000-00-00	No	No	Current