HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC
72189-191
11-digit product format
721890191
Labeler code
72189
Product ID
72189-191_2be977e6-4cfd-9a64-e063-6294a90a9fc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
DirectRx
Application
ANDA209037
Marketing category
ANDA
Marketing start
2021-09-15
Substance
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active strength
325; 7.5 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
72189-191-307218901913030 TABLET in 1 BOTTLE (72189-191-30) 30 tablet2021-09-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HYDROCODONE BITARTRATE AND ACETAMINOPHENDirectRx2025-01-17HUMAN PRESCRIPTION DRUG LABEL2