MEMANTINE HYDROCHLORIDE
- Product NDC
- 59651-407
- 11-digit product format
- 596510407
- Labeler code
- 59651
- Product ID
- 59651-407_7a208302-90f3-45d0-94fc-9fb38591c543
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MEMANTINE HYDROCHLORIDE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA214651
- Marketing category
- ANDA
- Marketing start
- 2021-08-09
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 28 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 |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-407-30 | 59651040730 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-407-30) | 2021-08-09 | No | No | Historical |
| 59651-407-90 | 59651040790 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-407-90) | 2021-08-09 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| MEMANTINE HYDROCHLORIDE | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED | 2022-11-05 | Human Prescription Drug Label | 2 |