memantine hydrochloride
- Product NDC
- 0615-8264
- 11-digit product format
- 006158264
- Labeler code
- 0615
- Product ID
- 0615-8264_194f162d-30bc-420f-85ae-fca98d00705a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA206028
- Marketing category
- ANDA
- Marketing start
- 2018-02-20
- Marketing end
- 2026-07-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- memantine hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEMANTINE HYDROCHLORIDE | 28 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JY0WD0UA60 |
| Rxcui | 996609 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8264-39 | memantine hydrochloride | 30 in 1 BLISTER PACK | CAPSULE, EXTENDED RELEASE | 30 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8264 | MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 16 | Current NDC, Legacy NDC, 1 package rows | 20240807_e2a371f6-8bfe-4049-b9ca-0ab3d726379e.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 |
|---|
| 0615-8264-39 | 00615826439 | 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8264-39) | 2019-01-09 | 2026-07-31 | No | No | Current |