Butalbital, Acetaminophen and Caffeine

Product NDC
71335-2272
11-digit product format
713352272
Labeler code
71335
Product ID
71335-2272_c421e413-0101-4319-9d31-93a666c56692
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
71335-2272-07133522720084 TABLET in 1 BOTTLE (71335-2272-0) 84 tablet2023-11-30NoNoHistorical
71335-2272-17133522720120 TABLET in 1 BOTTLE (71335-2272-1) 20 tablet2023-11-30NoNoHistorical
71335-2272-27133522720230 TABLET in 1 BOTTLE (71335-2272-2) 30 tablet2023-11-30NoNoHistorical
71335-2272-37133522720360 TABLET in 1 BOTTLE (71335-2272-3) 60 tablet2023-11-30NoNoHistorical
71335-2272-47133522720490 TABLET in 1 BOTTLE (71335-2272-4) 90 tablet2023-11-30NoNoHistorical
71335-2272-57133522720550 TABLET in 1 BOTTLE (71335-2272-5) 50 tablet2023-11-30NoNoHistorical
71335-2272-6713352272066 TABLET in 1 BOTTLE (71335-2272-6) 6 tablet2023-11-30NoNoHistorical
71335-2272-771335227207120 TABLET in 1 BOTTLE (71335-2272-7) 120 tablet2023-11-30NoNoHistorical
71335-2272-87133522720840 TABLET in 1 BOTTLE (71335-2272-8) 40 tablet2023-11-30NoNoHistorical
71335-2272-97133522720912 TABLET in 1 BOTTLE (71335-2272-9) 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