butalbital, acetaminophen and caffeine

Product NDC
72162-1096
11-digit product format
721621096
Labeler code
72162
Product ID
72162-1096_df9fcf32-6a10-4145-b273-dd7d4a1de486
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butalbital, acetaminophen and caffeine
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA212083
Marketing category
ANDA
Marketing start
2019-12-17
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
72162-1096-172162109601100 CAPSULE in 1 BOTTLE, PLASTIC (72162-1096-1) 100 capsule2024-01-31NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Butalbital, Acetaminophen, and Caffeine Capsules, USPBryant Ranch Prepack2024-01-31HUMAN PRESCRIPTION DRUG LABEL100