Butalbital, Acetaminophen, Caffeine and Codeine Phosphate

Product NDC
72162-1591
11-digit product format
721621591
Labeler code
72162
Product ID
72162-1591_215e2a6f-ec32-4836-8fad-22c8b40ba1f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076560
Marketing category
ANDA
Marketing start
2004-07-01
Substance
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Active strength
325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [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
GSL05Y1MN6CODEINE PHOSPHATE41444-62-6CODEINE PHOSPHATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1591-27216215910220 CAPSULE in 1 BOTTLE, PLASTIC (72162-1591-2) 20 capsule2024-04-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBryant Ranch Prepack2024-04-04HUMAN PRESCRIPTION DRUG LABEL101