Esgic

Product NDC: 68308-220
11-digit product format: 683080220
Labeler code: 68308
Product ID: 68308-220_ea240e69-9e4e-7af1-e053-2a95a90a29ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital, acetaminophen and caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Mayne Pharma Inc.
Application: ANDA089175
Marketing category: ANDA
Marketing start: 2014-05-01
Marketing end: 2025-03-31
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]
DEA schedule: CIII
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
68308-220-01	EA - Each	68308-220	1edd26b2-aa45-484e-8802-7e8906754888	1	2014-06-03

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
68308-220-01	68308022001	100 TABLET in 1 BOTTLE, PLASTIC (68308-220-01)	100 tablet	2014-05-01	0000-00-00	No	No	Current