Memantine Hydrochloride
- Product NDC
- 16571-853
- 11-digit product format
- 165710853
- Labeler code
- 16571
- Product ID
- 16571-853_4ece2bda-d26f-494f-93df-bc53c494caf9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA206032
- Marketing category
- ANDA
- Marketing start
- 2025-06-01
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 14 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| JY0WD0UA60 | MEMANTINE HYDROCHLORIDE | 41100-52-1 | MEMANTINE HYDROCHLORIDE |
| W8O17SJF3T | MEMANTINE | 19982-08-2 | memantine |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 16571-853-03 | 16571085303 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-853-03) | 2025-06-01 | No | No | Historical |
| 16571-853-09 | 16571085309 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (16571-853-09) | 2025-06-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Memantine Hydrochloride | Rising Pharma Holdings, Inc. | 2025-04-30 | HUMAN PRESCRIPTION DRUG LABEL | 3 |