Butalbital, Acetaminophen and Caffeine

Product NDC: 63629-2140
11-digit product format: 636292140
Labeler code: 63629
Product ID: 63629-2140_7631c97a-b405-4c93-8a41-0ca70b1c5fca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, and Caffeine
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA040511
Marketing category: ANDA
Marketing start: 2003-08-27
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]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2140-1	63629214001	500 TABLET in 1 BOTTLE (63629-2140-1)	500 tablet	2021-02-02	0000-00-00	No	No	Current