butalbital, acetaminophen and caffeine

Product NDC: 51862-540
11-digit product format: 518620540
Labeler code: 51862
Product ID: 51862-540_ea23805b-70aa-2efd-e053-2995a90a43af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: butalbital, acetaminophen and caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Mayne Pharma
Application: ANDA089175
Marketing category: ANDA
Marketing start: 2015-08-28
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
51862-540-01	EA - Each	51862-540	25b1b8f6-67da-4ca8-aad8-50ce53ecfa2e	1	2015-11-12
51862-540-05	EA - Each	51862-540	9d2657b1-aca8-4be9-979b-7bf40cf5547e	1	2015-11-12

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
51862-540-01	51862054001	100 TABLET in 1 BOTTLE, PLASTIC (51862-540-01)	100 tablet	2015-08-28	0000-00-00	No	No	Current
51862-540-05	51862054005	500 TABLET in 1 BOTTLE, PLASTIC (51862-540-05)	500 tablet	2015-08-28	0000-00-00	No	No	Current