NALTREXONE HYDROCHLORIDE

Product NDC
72162-2154
11-digit product format
721622154
Labeler code
72162
Product ID
72162-2154_ba53c1a1-0bc1-444f-9dc8-fbd07df724d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
naltrexone hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076264
Marketing category
ANDA
Marketing start
2002-03-22
Substance
NALTREXONE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
Z6375YW9SFNALTREXONE HYDROCHLORIDE16676-29-2NALTREXONE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2154-37216221540330 TABLET, FILM COATED in 1 BOTTLE (72162-2154-3) 2023-12-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Naltrexone Hydrochloride Tablets USP 50 mg Opioid Antagonist Rx onlyBryant Ranch Prepack2023-12-07HUMAN PRESCRIPTION DRUG LABEL100