BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product NDC
72162-1232
11-digit product format
721621232
Labeler code
72162
Product ID
72162-1232_e830bb30-27d1-4b2b-abfe-2ac29e0b9def
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butalbital, acetaminophen and caffeine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207118
Marketing category
ANDA
Marketing start
2017-01-10
Substance
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength
300; 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
72162-1232-172162123201100 CAPSULE in 1 BOTTLE (72162-1232-1) 100 capsule2023-10-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Butalbital, Acetaminophen and Caffeine Capsules, USPBryant Ranch Prepack2024-12-19HUMAN PRESCRIPTION DRUG LABEL101