HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
71335-0385
11-digit product format
713350385
Labeler code
71335
Product ID
71335-0385_3646bf17-9ab8-47ab-827c-0e6740db6f38
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
10 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
71335-0385-071335038500120 TABLET in 1 BOTTLE (71335-0385-0) 120 tablet2010-02-120000-00-00NoNoCurrent
71335-0385-17133503850120 TABLET in 1 BOTTLE (71335-0385-1) 20 tablet2010-02-120000-00-00NoNoCurrent
71335-0385-27133503850230 TABLET in 1 BOTTLE (71335-0385-2) 30 tablet2010-02-120000-00-00NoNoCurrent
71335-0385-37133503850340 TABLET in 1 BOTTLE (71335-0385-3) 40 tablet2010-02-120000-00-00NoNoCurrent
71335-0385-47133503850445 TABLET in 1 BOTTLE (71335-0385-4) 45 tablet2010-02-120000-00-00NoNoCurrent
71335-0385-57133503850556 TABLET in 1 BOTTLE (71335-0385-5) 56 tablet2010-02-120000-00-00NoNoCurrent
71335-0385-67133503850660 TABLET in 1 BOTTLE (71335-0385-6) 60 tablet2010-02-120000-00-00NoNoCurrent
71335-0385-77133503850784 TABLET in 1 BOTTLE (71335-0385-7) 84 tablet2010-02-120000-00-00NoNoCurrent
71335-0385-87133503850890 TABLET in 1 BOTTLE (71335-0385-8) 90 tablet2010-02-120000-00-00NoNoCurrent
71335-0385-971335038509100 TABLET in 1 BOTTLE (71335-0385-9) 100 tablet2010-02-120000-00-00NoNoCurrent