Memantine hydrochloride
- Product NDC
- 52605-072
- 11-digit product format
- 526050072
- Labeler code
- 52605
- Product ID
- 52605-072_4fe4f372-10c2-42ca-bc69-d78a489672b2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- POLYGEN PHARMACEUTICALS INC.
- Application
- ANDA210587
- Marketing category
- ANDA
- Marketing start
- 2021-07-01
- 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 |
|---|
| 52605-072-10 | Memantine hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 4 |
| 52605-072-13 | Memantine hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
| 52605-072-16 | Memantine hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52605-072 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [POLYGEN PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20221202_c343b0c5-3bfc-4b94-9483-a56924f6dcdb.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 |
|---|
| 52605-072-10 | 52605007210 | 1000 TABLET, FILM COATED in 1 BOTTLE (52605-072-10) | 2021-07-01 | 0000-00-00 | No | No | Current |
| 52605-072-13 | 52605007213 | 30 TABLET, FILM COATED in 1 BOTTLE (52605-072-13) | 2021-07-01 | 0000-00-00 | No | No | Current |
| 52605-072-16 | 52605007216 | 60 TABLET, FILM COATED in 1 BOTTLE (52605-072-16) | 2021-07-01 | 0000-00-00 | No | No | Current |