Hydrocodone Bitartrate and Acetaminophen

Product NDC
71335-2969
11-digit product format
713352969
Labeler code
71335
Product ID
71335-2969_41dc54e5-b4d3-e7ae-e063-6294a90a31f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA202214
Marketing category
ANDA
Marketing start
2014-10-06
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
NO70W886KKHYDROCODONE BITARTRATE34195-34-1HYDROCODONE BITARTRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2969-171335296901100 TABLET in 1 BOTTLE (71335-2969-1) 100 tablet2025-10-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydrocodone Bitartrate and AcetaminophenBryant Ranch Prepack2025-10-23HUMAN PRESCRIPTION DRUG LABEL100