Memantine Hydrochloride
- Product NDC
- 0904-6506
- 11-digit product format
- 009046506
- Labeler code
- 0904
- Product ID
- 0904-6506_f98561aa-0a02-4e99-bacb-d92c81833bbe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA090048
- Marketing category
- ANDA
- Marketing start
- 2015-07-20
- 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 Hydrochloride
- 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, 996571 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-6506-06 | Memantine Hydrochloride | 50 in 1 CARTON | TABLET, FILM COATED | 50 | | 8 |
| 0904-6506-06 | Memantine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 8 |
| 0904-6506-61 | Memantine Hydrochloride | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 8 |
| 0904-6506-61 | Memantine Hydrochloride | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-6506 | MEMANTINE TABLET [MAJOR PHARMACEUTICALS] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240724_d0a5e0fc-04e3-417d-bef3-9b309ff71597.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 |
|---|
| 0904-6506-06 | 00904650606 | 50 BLISTER PACK in 1 CARTON (0904-6506-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 50 blister pack | 2015-07-20 | 0000-00-00 | No | No | Current |
| 0904-6506-61 | 00904650661 | 100 BLISTER PACK in 1 CARTON (0904-6506-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2015-07-20 | 0000-00-00 | No | No | Current |