Memantine
- Product NDC
- 0615-8319
- 11-digit product format
- 006158319
- Labeler code
- 0615
- Product ID
- 0615-8319_f52d94bf-167f-48f1-bc69-37bc8acde5df
- 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
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Memantine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEMANTINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JY0WD0UA60 |
| Rxcui | 996561 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8319-05 | Memantine | 15 in 1 BLISTER PACK | TABLET | 15 | | 3 |
| 0615-8319-39 | Memantine | 30 in 1 BLISTER PACK | TABLET | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8319 | MEMANTINE TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240816_5c8a168d-aef5-4ac7-b8c1-3812a8c228ab.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 |
|---|
| 0615-8319-05 | 00615831905 | 15 TABLET in 1 BLISTER PACK (0615-8319-05) | 15 tablet | 2019-09-03 | 0000-00-00 | No | No | Current |
| 0615-8319-39 | 00615831939 | 30 TABLET in 1 BLISTER PACK (0615-8319-39) | 30 tablet | 2019-09-03 | 0000-00-00 | No | No | Current |