Butalbital, Acetaminophen and Caffeine

Product NDC
67296-2204
11-digit product format
672962204
Labeler code
67296
Product ID
67296-2204_4727e80e-b59e-3abc-e063-6294a90a1294
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Redpharm Drug
Application
ANDA211106
Marketing category
ANDA
Marketing start
2018-09-26
Substance
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength
325; 50; 40 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
KHS0AZ4JVKBUTALBITAL77-26-9BUTALBITAL
3G6A5W338ECAFFEINE58-08-2CAFFEINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67296-2204-16729622040120 TABLET in 1 BOTTLE (67296-2204-1) 20 tablet2018-09-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Butalbital, Acetaminophen and Caffeine Tablets, USP 50 mg/325 mg/40 mg Rx OnlyRedpharm Drug2025-12-30HUMAN PRESCRIPTION DRUG LABEL1