NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride Tablets, USP Opioid Antagonist
Approved
Approval ID
69cb8573-08c1-4957-a768-6cd383f6a3f4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2021
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
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 Code0904-7036
Application NumberANDA090356
Product Classification
M
Marketing Category
C73584
G
Generic Name
NALTREXONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 27, 2020
FDA Product Classification
INGREDIENTS (12)
NALTREXONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: Z6375YW9SF
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT