Memantine Hydrochloride
- Product NDC
- 65162-785
- 11-digit product format
- 651620785
- Labeler code
- 65162
- Product ID
- 65162-785_fb7782a5-2357-4a21-86a6-0eeaa7cdcea5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA205825
- Marketing category
- ANDA
- Marketing start
- 2017-12-22
- 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
- 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 | 28 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 |
|---|
| 65162-785-03 | Memantine Hydrochloride | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | | 19 |
| 65162-785-09 | Memantine Hydrochloride | 90 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 90 | | 19 |
| 65162-785-50 | Memantine Hydrochloride | 500 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 500 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-785 | MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC] | 19 | Current NDC, Legacy NDC, 3 package rows | 20250430_f2b7538d-8ca1-4ac7-a172-d268e2fa9a52.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 |
|---|
| 65162-785-03 | 65162078503 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-785-03) | 2017-12-22 | 0000-00-00 | No | No | Current |
| 65162-785-09 | 65162078509 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-785-09) | 2017-12-22 | 0000-00-00 | No | No | Current |
| 65162-785-50 | 65162078550 | 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65162-785-50) | 2017-12-22 | 0000-00-00 | No | No | Current |