NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride Tablets USP50 mgOpioid AntagonistRx only
Approved
Approval ID
06ff2d5a-e62b-4fa4-bbdb-01938535bc65
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 6, 2022
Manufacturers
FDA
SpecGx LLC
DUNS: 080679498
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 Code0406-1170
Application NumberANDA076264
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 6, 2022
Generic Namenaltrexone hydrochloride
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
NALTREXONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: Z6375YW9SF
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT