HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
71335-0063
11-digit product format
713350063
Labeler code
71335
Product ID
71335-0063_7360a421-4a22-4d33-a0c1-10b898e424c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090118
Marketing category
ANDA
Marketing start
2009-03-30
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
8 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0063-0713350063008 TABLET in 1 BOTTLE (71335-0063-0) 8 tablet2010-08-020000-00-00NoNoCurrent
71335-0063-171335006301120 TABLET in 1 BOTTLE (71335-0063-1) 120 tablet2010-08-020000-00-00NoNoCurrent
71335-0063-27133500630215 TABLET in 1 BOTTLE (71335-0063-2) 15 tablet2010-08-020000-00-00NoNoCurrent
71335-0063-37133500630320 TABLET in 1 BOTTLE (71335-0063-3) 20 tablet2010-08-020000-00-00NoNoCurrent
71335-0063-47133500630428 TABLET in 1 BOTTLE (71335-0063-4) 28 tablet2010-08-020000-00-00NoNoCurrent
71335-0063-57133500630530 TABLET in 1 BOTTLE (71335-0063-5) 30 tablet2010-08-020000-00-00NoNoCurrent
71335-0063-67133500630640 TABLET in 1 BOTTLE (71335-0063-6) 40 tablet2010-08-020000-00-00NoNoCurrent
71335-0063-77133500630756 TABLET in 1 BOTTLE (71335-0063-7) 56 tablet2010-08-020000-00-00NoNoCurrent
71335-0063-87133500630860 TABLET in 1 BOTTLE (71335-0063-8) 60 tablet2010-08-020000-00-00NoNoCurrent
71335-0063-97133500630990 TABLET in 1 BOTTLE (71335-0063-9) 90 tablet2010-08-020000-00-00NoNoCurrent