Naltrexone Hydrochloride
Naltrexone Hydrochloride Tablets, USP 50 mg
Approved
Approval ID
48f0b37b-b1cb-4cc9-ae58-4695e9a501e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-3076
Application NumberANDA075274
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 18, 2019
Generic NameNaltrexone Hydrochloride
INGREDIENTS (11)
NALTREXONE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: Z6375YW9SF
Classification: ACTIB
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
hydroxypropyl cellulose (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
hypromellose, unspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
polyethylene glycol, unspecifiedInactive
Code: 3WJQ0SDW1A
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT