Butalbital, Acetaminophen and Caffeine

Product NDC
71335-2270
11-digit product format
713352270
Labeler code
71335
Product ID
71335-2270_0e3608c9-b97a-4f77-9cd8-d63f6d55cab1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040864
Marketing category
ANDA
Marketing start
2022-06-29
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
71335-2270-07133522700084 TABLET in 1 BOTTLE (71335-2270-0) 84 tablet2023-11-30NoNoHistorical
71335-2270-17133522700120 TABLET in 1 BOTTLE (71335-2270-1) 20 tablet2023-11-30NoNoHistorical
71335-2270-27133522700230 TABLET in 1 BOTTLE (71335-2270-2) 30 tablet2023-11-30NoNoHistorical
71335-2270-37133522700360 TABLET in 1 BOTTLE (71335-2270-3) 60 tablet2023-11-30NoNoHistorical
71335-2270-47133522700490 TABLET in 1 BOTTLE (71335-2270-4) 90 tablet2023-11-30NoNoHistorical
71335-2270-57133522700550 TABLET in 1 BOTTLE (71335-2270-5) 50 tablet2023-11-30NoNoHistorical
71335-2270-6713352270066 TABLET in 1 BOTTLE (71335-2270-6) 6 tablet2023-11-30NoNoHistorical
71335-2270-771335227007120 TABLET in 1 BOTTLE (71335-2270-7) 120 tablet2023-11-30NoNoHistorical
71335-2270-87133522700840 TABLET in 1 BOTTLE (71335-2270-8) 40 tablet2023-11-30NoNoHistorical
71335-2270-97133522700912 TABLET in 1 BOTTLE (71335-2270-9) 12 tablet2023-11-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Butalbital, Acetaminophen and Caffeine Tablets, USP 50 mg/325 mg/40 mg, Clll Rx onlyBryant Ranch Prepack2023-11-30HUMAN PRESCRIPTION DRUG LABEL100