DONEPEZIL HYDROCHLORIDE
These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE
Approved
Approval ID
0baef0fd-e6c0-4ee8-bb7e-1d2e89d6e0ec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2019
Manufacturers
FDA
Jubilant Cadista Pharmaceuticals Inc.
DUNS: 022490515
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 Code59746-329
Application NumberANDA090768
Product Classification
M
Marketing Category
C73584
G
Generic Name
DONEPEZIL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2019
FDA Product Classification
INGREDIENTS (10)
Donepezil HydrochlorideActive
Quantity: 5 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Polyethylene Glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
Hypromellose 2910 (6 Mpa.s)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
DONEPEZIL HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-330
Application NumberANDA090768
Product Classification
M
Marketing Category
C73584
G
Generic Name
DONEPEZIL HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 26, 2019
FDA Product Classification
INGREDIENTS (10)
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Donepezil HydrochlorideActive
Quantity: 10 mg in 1 1
Code: 3O2T2PJ89D
Classification: ACTIB
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Hydroxypropyl Cellulose, Low SubstitutedInactive
Code: 2165RE0K14
Classification: IACT
Hypromellose 2910 (6 Mpa.s)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Polyethylene Glycol 8000Inactive
Code: Q662QK8M3B
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT