Butalbital, Acetaminophen and Caffeine

Product NDC
71335-1977
11-digit product format
713351977
Labeler code
71335
Product ID
71335-1977_8e84c887-4300-4fa2-a9db-ccae0efb8985
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040511
Marketing category
ANDA
Marketing start
2003-08-27
Marketing end
0000-00-00
Substance
BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active strength
50 mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1977-07133519770084 TABLET in 1 BOTTLE, PLASTIC (71335-1977-0) 84 tablet2021-11-010000-00-00NoNoCurrent
71335-1977-17133519770120 TABLET in 1 BOTTLE, PLASTIC (71335-1977-1) 20 tablet2021-11-010000-00-00NoNoCurrent
71335-1977-27133519770230 TABLET in 1 BOTTLE, PLASTIC (71335-1977-2) 30 tablet2021-11-010000-00-00NoNoCurrent
71335-1977-37133519770360 TABLET in 1 BOTTLE, PLASTIC (71335-1977-3) 60 tablet2021-11-010000-00-00NoNoCurrent
71335-1977-47133519770490 TABLET in 1 BOTTLE, PLASTIC (71335-1977-4) 90 tablet2021-11-010000-00-00NoNoCurrent
71335-1977-57133519770550 TABLET in 1 BOTTLE, PLASTIC (71335-1977-5) 50 tablet2021-11-010000-00-00NoNoCurrent
71335-1977-6713351977066 TABLET in 1 BOTTLE, PLASTIC (71335-1977-6) 6 tablet2021-11-010000-00-00NoNoCurrent
71335-1977-771335197707120 TABLET in 1 BOTTLE, PLASTIC (71335-1977-7) 120 tablet2021-11-010000-00-00NoNoCurrent
71335-1977-87133519770840 TABLET in 1 BOTTLE, PLASTIC (71335-1977-8) 40 tablet2021-11-010000-00-00NoNoCurrent
71335-1977-97133519770912 TABLET in 1 BOTTLE, PLASTIC (71335-1977-9) 12 tablet2021-11-010000-00-00NoNoCurrent