Memantine Hydrochloride
- Product NDC
- 69680-161
- 11-digit product format
- 696800161
- Labeler code
- 69680
- Product ID
- 69680-161_64b8e27d-8127-4df2-a089-dbcd873c4e5e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Vitruvias Therapeutics, Inc.
- Application
- ANDA213985
- Marketing category
- ANDA
- Marketing start
- 2023-12-15
- Substance
- MEMANTINE HYDROCHLORIDE
- Active strength
- 7 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 | 7 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JY0WD0UA60 |
| Rxcui | 996594, 996603, 996609, 996615 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69680-161-30 | Memantine Hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69680-161 | MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [VITRUVIAS THERAPEUTICS, INC.] | 2 | Current NDC, 1 package rows | 20240219_0c7fd6ab-2ce5-4110-b6e6-9103c8da0765.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69680-161-30 | 69680016130 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-161-30) | 2023-12-15 | No | No | Current |