BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product NDC: 55154-7147
11-digit product format: 551547147
Labeler code: 55154
Product ID: 55154-7147_37a703ec-18bd-4e08-bbb5-278b8158a89b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Dosage form: TABLET
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA040511
Marketing category: ANDA
Marketing start: 2012-06-01
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]
DEA schedule: CIII
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55154-7147-0	2021-04-22	C162847	48780-1	9d75b9d1-13ad-f424-e053-dadaa90a57ce	92a81a1f-698b-4db0-b5a6-f7562abd9a32
55154-7147-0	2020-01-31	C162847	48780-1	9d75b9d1-13ad-f424-e053-dadaa90a57ce	92a81a1f-698b-4db0-b5a6-f7562abd9a32

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
55154-7147-0	55154714700	10 BLISTER PACK in 1 BAG (55154-7147-0) > 1 TABLET in 1 BLISTER PACK	10 blister pack	2012-06-01	0000-00-00	No	No	Current