Hydrocodone Bitartrate and Ibuprofen

Product NDC
71335-0104
11-digit product format
713350104
Labeler code
71335
Product ID
71335-0104_4e63cb6c-5d07-43b8-9228-83a1b79952c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076642
Marketing category
ANDA
Marketing start
2010-02-18
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; IBUPROFEN
Active strength
8 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
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
71335-0104-07133501040015 TABLET in 1 BOTTLE (71335-0104-0) 15 tablet2021-12-270000-00-00NoNoCurrent
71335-0104-171335010401120 TABLET in 1 BOTTLE (71335-0104-1) 120 tablet2018-10-100000-00-00NoNoCurrent
71335-0104-27133501040220 TABLET in 1 BOTTLE (71335-0104-2) 20 tablet2021-12-270000-00-00NoNoCurrent
71335-0104-37133501040328 TABLET in 1 BOTTLE (71335-0104-3) 28 tablet2021-12-270000-00-00NoNoCurrent
71335-0104-47133501040430 TABLET in 1 BOTTLE (71335-0104-4) 30 tablet2021-12-270000-00-00NoNoCurrent
71335-0104-57133501040540 TABLET in 1 BOTTLE (71335-0104-5) 40 tablet2021-12-270000-00-00NoNoCurrent
71335-0104-67133501040645 TABLET in 1 BOTTLE (71335-0104-6) 45 tablet2021-12-270000-00-00NoNoCurrent
71335-0104-77133501040760 TABLET in 1 BOTTLE (71335-0104-7) 60 tablet2018-09-140000-00-00NoNoCurrent
71335-0104-87133501040884 TABLET in 1 BOTTLE (71335-0104-8) 84 tablet2021-12-270000-00-00NoNoCurrent
71335-0104-97133501040990 TABLET in 1 BOTTLE (71335-0104-9) 90 tablet2021-12-270000-00-00NoNoCurrent