Memantine Hydrochloride
- Product NDC
- 68788-8647
- 11-digit product format
- 687888647
- Labeler code
- 68788
- Product ID
- 68788-8647_49c19bbd-4d60-4f50-9cec-62b0074ffd08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA206528
- Marketing category
- ANDA
- Marketing start
- 2024-05-01
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
openFDA Listing Details
- Product ID
- 68788-8647_49c19bbd-4d60-4f50-9cec-62b0074ffd08
- SPL ID
- 49c19bbd-4d60-4f50-9cec-62b0074ffd08
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Memantine Hydrochloride
- Generic name
- Memantine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2024-05-01
- Marketing category
- ANDA
- Application number
- ANDA206528
- Pharmacologic classes
- N-methyl-D-aspartate Receptor Antagonist [EPC]; NMDA Receptor Antagonists [MoA]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| MEMANTINE HYDROCHLORIDE | 10 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | JY0WD0UA60 |
| Rxcui | 996561 |
| Spl Set Id | becb09dc-174d-4817-88d4-f38c8adcd309 |
| Manufacturer Name | Preferred Pharmaceuticals Inc. |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 68788-8647-3 | 30 TABLET in 1 BOTTLE (68788-8647-3) | 2024-05-01 | No |
| 68788-8647-6 | 60 TABLET in 1 BOTTLE (68788-8647-6) | 2024-05-01 | No |
| 68788-8647-9 | 90 TABLET in 1 BOTTLE (68788-8647-9) | 2024-05-01 | No |
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| JY0WD0UA60 | MEMANTINE HYDROCHLORIDE | 41100-52-1 | MEMANTINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8647-3 | 68788864703 | 30 TABLET in 1 BOTTLE (68788-8647-3) | 30 tablet | 2024-05-01 | No | No | Historical |
| 68788-8647-6 | 68788864706 | 60 TABLET in 1 BOTTLE (68788-8647-6) | 60 tablet | 2024-05-01 | No | No | Historical |
| 68788-8647-9 | 68788864709 | 90 TABLET in 1 BOTTLE (68788-8647-9) | 90 tablet | 2024-05-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Memantine Hydrochloride | Preferred Pharmaceuticals Inc. | 2025-08-05 | HUMAN PRESCRIPTION DRUG LABEL | 2 |