Hydrocodone Bitartrate and Acetaminophen

Product NDC
71335-0960
11-digit product format
713350960
Labeler code
71335
Product ID
71335-0960_346612cc-9d0c-45e2-a04d-fa22f82f2e4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201013
Marketing category
ANDA
Marketing start
2012-04-11
Marketing end
0000-00-00
Substance
HYDROCODONE BITARTRATE; ACETAMINOPHEN
Active strength
5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0960-1EA - Each71335-096099b10b21-8993-49e7-a801-a5cc0388340812019-03-12
71335-0960-2EA - Each71335-096011d1242c-209a-4fcc-8862-ccd7e2e15dfb12019-03-12
71335-0960-4EA - Each71335-0960618b3021-4211-4560-984a-e05bcfbf9f8812019-03-12
71335-0960-5EA - Each71335-0960b7025f8a-4b2e-4a75-b7de-28c5fe0a963712019-03-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0960-07133509600010 TABLET in 1 BOTTLE (71335-0960-0) 10 tablet2018-10-040000-00-00NoNoCurrent
71335-0960-17133509600130 TABLET in 1 BOTTLE (71335-0960-1) 30 tablet2018-10-040000-00-00NoNoCurrent
71335-0960-271335096002120 TABLET in 1 BOTTLE (71335-0960-2) 120 tablet2018-10-040000-00-00NoNoCurrent
71335-0960-37133509600320 TABLET in 1 BOTTLE (71335-0960-3) 20 tablet2018-10-040000-00-00NoNoCurrent
71335-0960-47133509600460 TABLET in 1 BOTTLE (71335-0960-4) 60 tablet2018-10-040000-00-00NoNoCurrent
71335-0960-57133509600590 TABLET in 1 BOTTLE (71335-0960-5) 90 tablet2018-10-040000-00-00NoNoCurrent
71335-0960-6713350960068 TABLET in 1 BOTTLE (71335-0960-6) 8 tablet2018-10-040000-00-00NoNoCurrent
71335-0960-77133509600740 TABLET in 1 BOTTLE (71335-0960-7) 40 tablet2018-10-040000-00-00NoNoCurrent
71335-0960-87133509600815 TABLET in 1 BOTTLE (71335-0960-8) 15 tablet2018-10-040000-00-00NoNoCurrent
71335-0960-97133509600984 TABLET in 1 BOTTLE (71335-0960-9) 84 tablet2018-10-040000-00-00NoNoCurrent