Butalbital, Acetaminophen and Caffeine

Product NDC: 68084-396
11-digit product format: 680840396
Labeler code: 68084
Product ID: 68084-396_eb6af194-aa1d-a7ab-e053-2995a90a8278
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Butalbital, Acetaminophen and Caffeine
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA040511
Marketing category: ANDA
Marketing start: 2009-09-08
Marketing end: 2024-03-31
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
68084-396-01	EA - Each	68084-396	4943dea1-3e74-4f68-8f15-70c89d2c66f2	1	2012-07-24
68084-396-11	EA - Each	68084-396	b6c42235-80eb-4c82-9332-36d4a54fedb8	1	2012-07-24
68084-396-65	EA - Each	68084-396	38062f14-f7f9-49f4-9cb3-202868f96081	1	2014-10-03

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
68084-396-65	68084039665	50 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-396-65) > 1 TABLET in 1 BLISTER PACK (68084-396-11)	50 blister pack	2014-07-28	0000-00-00	No	No	Current