butalbital, acetaminophen and caffeine

Product NDC: 51862-542
11-digit product format: 518620542
Labeler code: 51862
Product ID: 51862-542_ea233792-038e-39e7-e053-2995a90a20ad
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital, acetaminophen and caffeine
Dosage form: CAPSULE
Route: ORAL
Labeler: Mayne Pharma
Application: ANDA210817
Marketing category: ANDA
Marketing start: 2020-03-09
Marketing end: 2022-12-31
Substance: ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength: 300 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
51862-542-01	EA - Each	51862-542	07d1b083-e3b5-4a54-9db0-68fabfa6ff8a	1	2020-05-08

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
51862-542-01	51862054201	100 CAPSULE in 1 BOTTLE, PLASTIC (51862-542-01)	100 capsule	2020-03-09	0000-00-00	No	No	Current