Naltrexone Hydrochloride
Naltrexone Hydrochloride Tablets, USP 50 mgOpioid AntagonistRx only
Approved
Approval ID
c67a22bb-d2bd-4da5-9d3e-6b5281f10891
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 8, 2023
Manufacturers
FDA
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc
DUNS: 780779901
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Naltrexone Hydrochloride
PRODUCT DETAILS
NDC Product Code23155-886
Application NumberANDA207905
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 3, 2023
Generic NameNaltrexone Hydrochloride
INGREDIENTS (10)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
NALTREXONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: Z6375YW9SF
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT