Memantine
- Product NDC
- 0615-8192
- 11-digit product format
- 006158192
- Labeler code
- 0615
- Product ID
- 0615-8192_b4ebdb70-3b13-4041-a691-3adb3dc6687b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA090048
- Marketing category
- ANDA
- Marketing start
- 2015-07-11
- 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
- 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 |
|---|
| 0615-8192-39 | Memantine | 30 in 1 BLISTER PACK | TABLET | 30 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8192 | MEMANTINE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 11 | Current NDC, Legacy NDC, 1 package rows | 20240814_a5dcc0e7-761f-4294-bb48-e5ee4a1e2f67.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0615-8192-39 | 00615819239 | 30 TABLET in 1 BLISTER PACK (0615-8192-39) | 30 tablet | 2018-04-06 | 0000-00-00 | No | No | Current |