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NDC 68382-0548-16 Memantine hydrochloride 21 mg/1 Details
Memantine hydrochloride 21 mg/1
Memantine hydrochloride is a ORAL CAPSULE, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Zydus Pharmaceuticals USA Inc.. The primary component is MEMANTINE HYDROCHLORIDE.
MedlinePlus Drug Summary
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: 68382-0548-16Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Memantine
Product Information
| NDC | 68382-0548 |
|---|---|
| Product ID | 68382-548_079cb172-4d62-4571-98b9-5ad01706dbee |
| Associated GPIs | 62053550107040 |
| GCN Sequence Number | 070869 |
| GCN Sequence Number Description | memantine HCl CAP SPR 24 21 MG ORAL |
| HIC3 | H1A |
| HIC3 Description | ALZHEIMER'S THERAPY, NMDA RECEPTOR ANTAGONISTS |
| GCN | 34526 |
| HICL Sequence Number | 013778 |
| HICL Sequence Number Description | MEMANTINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Memantine hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Memantine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 21 |
| Active Ingredient Units | mg/1 |
| Substance Name | MEMANTINE HYDROCHLORIDE |
| Labeler Name | Zydus Pharmaceuticals USA Inc. |
| Pharmaceutical Class | N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA203293 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68382-0548-16 (68382054816)
| NDC Package Code | 68382-548-16 |
|---|---|
| Billing NDC | 68382054816 |
| Package | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-548-16) |
| Marketing Start Date | 2018-04-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |