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NDC 70518-0452-00 donepezil hydrochloride 5 mg/1 Details
donepezil hydrochloride 5 mg/1
donepezil hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by REMEDYREPACK INC.. The primary component is DONEPEZIL HYDROCHLORIDE.
MedlinePlus Drug Summary
Donepezil is used to treat dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and may cause changes in mood and personality) in people who have Alzheimer's disease (AD; a brain disease that slowly destroys the memory and the ability to think, learn, communicate and handle daily activities). Donepezil is in a class of medications called cholinesterase inhibitors. It improves mental function (such as memory, attention, the ability to interact with others, speak, think clearly, and perform regular daily activities) by increasing the amount of a certain naturally occurring substance in the brain. Donepezil may improve the ability to think and remember or slow the loss of these abilities in people who have AD. However, donepezil will not cure AD or prevent the loss of mental abilities at some time in the future.
Related Packages: 70518-0452-00Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Donepezil
Product Information
| NDC | 70518-0452 |
|---|---|
| Product ID | 70518-0452_0e36c039-1f22-2004-e063-6394a90addf4 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | donepezil hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | donepezil hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | DONEPEZIL HYDROCHLORIDE |
| Labeler Name | REMEDYREPACK INC. |
| Pharmaceutical Class | Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA200292 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 70518-0452-00 (70518045200)
| NDC Package Code | 70518-0452-0 |
|---|---|
| Billing NDC | 70518045200 |
| Package | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0452-0) |
| Marketing Start Date | 2017-04-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |