Hydrocodone Bitartrate and Acetaminophen

Product NDC
71335-2144
11-digit product format
713352144
Labeler code
71335
Product ID
71335-2144_2a485efe-a87c-4c55-9e17-7891b2fffb83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrocodone Bitartrate and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210211
Marketing category
ANDA
Marketing start
2018-07-13
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
71335-2144-07133521440010 TABLET in 1 BOTTLE (71335-2144-0) 10 tablet2022-08-01NoNoHistorical
71335-2144-17133521440130 TABLET in 1 BOTTLE (71335-2144-1) 30 tablet2024-09-06NoNoHistorical
71335-2144-271335214402120 TABLET in 1 BOTTLE (71335-2144-2) 120 tablet2024-09-06NoNoHistorical
71335-2144-37133521440320 TABLET in 1 BOTTLE (71335-2144-3) 20 tablet2022-08-01NoNoHistorical
71335-2144-47133521440460 TABLET in 1 BOTTLE (71335-2144-4) 60 tablet2024-09-06NoNoHistorical
71335-2144-57133521440590 TABLET in 1 BOTTLE (71335-2144-5) 90 tablet2024-09-06NoNoHistorical
71335-2144-67133521440650 TABLET in 1 BOTTLE (71335-2144-6) 50 tablet2024-09-06NoNoHistorical
71335-2144-77133521440740 TABLET in 1 BOTTLE (71335-2144-7) 40 tablet2024-09-06NoNoHistorical
71335-2144-87133521440815 TABLET in 1 BOTTLE (71335-2144-8) 15 tablet2024-09-06NoNoHistorical
71335-2144-97133521440984 TABLET in 1 BOTTLE (71335-2144-9) 84 tablet2024-09-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Revised: 01/2024Bryant Ranch Prepack2024-09-06HUMAN PRESCRIPTION DRUG LABEL102