Naltrexone Hydrochloride
Naltrexone Hydrochloride Tablets USP, film coated
Approved
Approval ID
74087d2f-468d-4de1-a2fc-a489d0f2abef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 16, 2022
Manufacturers
FDA
Precision Dose Inc.
DUNS: 035886746
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 Code68094-853
Application NumberANDA075274
Product Classification
M
Marketing Category
C73584
G
Generic Name
naltrexone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2022
FDA Product Classification
INGREDIENTS (11)
naltrexone HydrochlorideActive
Quantity: 50 mg in 1 1
Code: Z6375YW9SF
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT