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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-886
Application NumberANDA207905
Product Classification
M
Marketing Category
C73584
G
Generic Name
Naltrexone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
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