Esgic

Product NDC: 68308-219
11-digit product format: 683080219
Labeler code: 68308
Product ID: 68308-219_ed0bf5f2-521e-27fe-e053-2995a90ab13b
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: 2014-05-01
Marketing end: 0000-00-00
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: 2023-12-31
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
68308-219-01	EA - Each	68308-219	f5f7325d-6a36-4ea0-b22a-f5c8b0a53c5e	1	2014-05-02

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
68308-219-01	68308021901	100 CAPSULE in 1 BOTTLE, PLASTIC (68308-219-01)	100 capsule	2014-05-01	0000-00-00	No	No	Current