memantine hydrochloride
- Product NDC
- 65162-173
- 11-digit product format
- 651620173
- Labeler code
- 65162
- Product ID
- 65162-173_e3662d8d-b6da-40c6-84d4-1b5d467b1eb8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA090041
- Marketing category
- ANDA
- Marketing start
- 2022-03-24
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 5 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- memantine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEMANTINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JY0WD0UA60 |
| Rxcui | 996561, 996571 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-173-06 | memantine hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-173 | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240208_f73e0df0-4af4-42f1-bde6-3cccb47ca378.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-173-06 | 65162017306 | 60 TABLET, FILM COATED in 1 BOTTLE (65162-173-06) | 2022-03-24 | 0000-00-00 | No | No | Current |