Butalbital, Acetaminophen, Caffeine

Product NDC: 55700-920
11-digit product format: 557000920
Labeler code: 55700
Product ID: 55700-920_a433a5a4-6b7b-47e4-89ff-1b2d7fad638c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen, and Caffeine
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Quality Care Products, LLC
Application: ANDA209587
Marketing category: ANDA
Marketing start: 2021-07-29
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55700-920-12	EA - Each	55700-920	bcb4d217-21c8-4709-ac32-1c58fa37ea70	1	2021-10-08
55700-920-30	EA - Each	55700-920	294e381b-ad3a-471a-adf0-1c3bf25637c3	1	2021-10-08

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	Marketing start	Marketing end	Sample	Exclude flag	Status
55700-920-12	55700092012	12 TABLET, COATED in 1 BOTTLE (55700-920-12)	2021-09-10	0000-00-00	No	No	Current
55700-920-30	55700092030	30 TABLET, COATED in 1 BOTTLE (55700-920-30)	2021-07-29	0000-00-00	No	No	Current