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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-1170
Application NumberANDA076264
Product Classification
M
Marketing Category
C73584
G
Generic Name
naltrexone hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 6, 2022
FDA Product Classification
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