Memantine Hydrochloride
- Product NDC
- 33342-297
- 11-digit product format
- 333420297
- Labeler code
- 33342
- Product ID
- 33342-297_672222e3-12b9-488f-a5ee-c47736d65cce
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA202840
- Marketing category
- ANDA
- Marketing start
- 2015-10-13
- 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 Hydrochloride
- 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 |
|---|
| 33342-297-09 | Memantine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 6 |
| 33342-297-12 | Memantine Hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | | 6 |
| 33342-297-12 | Memantine Hydrochloride | 10 in 1 CARTON | TABLET | 10 | | 6 |
| 33342-297-15 | Memantine Hydrochloride | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33342-297 | MEMANTINE HYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED] | 6 | Current NDC, Legacy NDC, 4 package rows | 20230101_989fa756-7d70-4ea7-bb5e-f4395e48589d.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 |
|---|
| 33342-297-09 | 33342029709 | 60 TABLET in 1 BOTTLE (33342-297-09) | 60 tablet | 2015-10-13 | 0000-00-00 | No | No | Current |
| 33342-297-12 | 33342029712 | 10 BLISTER PACK in 1 CARTON (33342-297-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2015-10-13 | 0000-00-00 | No | No | Current |
| 33342-297-15 | 33342029715 | 500 TABLET in 1 BOTTLE (33342-297-15) | 500 tablet | 2015-10-13 | 0000-00-00 | No | No | Current |