Adlarity
These highlights do not include all the information needed to use ADLARITY safely and effectively. See full prescribing information for ADLARITY. ADLARITY® (donepezil transdermal system) Initial U.S. Approval : 1996
Approved
Approval ID
1cb44c65-00e8-4b5c-99c2-ad15173115a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2023
Manufacturers
FDA
Corium, LLC.
DUNS: 839674207
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Donepezil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65038-055
Application NumberNDA212304
Product Classification
M
Marketing Category
C73594
G
Generic Name
Donepezil Hydrochloride
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateFebruary 17, 2023
FDA Product Classification
INGREDIENTS (8)
Donepezil hydrochlorideActive
Quantity: 5 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Sorbitan MonolaurateInactive
Code: 6W9PS8B71J
Classification: IACT
CrospovidoneInactive
Code: 2S7830E561
Classification: IACT
Lauryl LactateInactive
Code: G5SU0BFK7O
Classification: IACT
Sodium BicarbonateInactive
Code: 8MDF5V39QO
Classification: IACT
Ascorbyl PalmitateInactive
Code: QN83US2B0N
Classification: IACT
Donepezil Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65038-056
Application NumberNDA212304
Product Classification
M
Marketing Category
C73594
G
Generic Name
Donepezil Hydrochloride
Product Specifications
Route of AdministrationTRANSDERMAL
Effective DateFebruary 17, 2023
FDA Product Classification
INGREDIENTS (8)
Donepezil hydrochlorideActive
Quantity: 10 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Triethyl CitrateInactive
Code: 8Z96QXD6UM
Classification: IACT
Sorbitan MonolaurateInactive
Code: 6W9PS8B71J
Classification: IACT
Sodium BicarbonateInactive
Code: 8MDF5V39QO
Classification: IACT
CrospovidoneInactive
Code: 2S7830E561
Classification: IACT
Lauryl LactateInactive
Code: G5SU0BFK7O
Classification: IACT
Ascorbyl PalmitateInactive
Code: QN83US2B0N
Classification: IACT