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NDC 69238-1553-09 Memantine and Donepezil Hydrochlorides Extended-release 10; 21 mg/1; mg/1 Details
Memantine and Donepezil Hydrochlorides Extended-release 10; 21 mg/1; mg/1
Memantine and Donepezil Hydrochlorides Extended-release is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals NY LLC. The primary component is DONEPEZIL HYDROCHLORIDE; MEMANTINE 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: 69238-1553-09Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Donepezil
Memantine is used to treat the symptoms of Alzheimer's disease (AD; a brain disease that slowly destroys the memory and the ability to think, learn, communicate and handle daily activities). Memantine is in a class of medications called NMDA receptor antagonists. It works by decreasing abnormal activity in the brain. Memantine may improve the ability to think and remember or may slow the loss of these abilities in people who have AD. However, memantine will not cure AD or prevent the loss of these abilities at some time in the future.
Related Packages: 69238-1553-09Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Memantine
Product Information
| NDC | 69238-1553 |
|---|---|
| Product ID | 69238-1553_8318c463-e796-4d9a-b86b-700cf42fedf4 |
| 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 | Memantine and Donepezil Hydrochlorides Extended-release |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Memantine and Donepezil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 10; 21 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE |
| Labeler Name | Amneal Pharmaceuticals NY LLC |
| Pharmaceutical Class | Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208328 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69238-1553-09 (69238155309)
| NDC Package Code | 69238-1553-9 |
|---|---|
| Billing NDC | 69238155309 |
| Package | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-1553-9) |
| Marketing Start Date | 2017-02-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |