memantine hydrochloride
- Product NDC
- 31722-808
- 11-digit product format
- 317220808
- Labeler code
- 31722
- Product ID
- 31722-808_eabf0e61-425e-9c9f-e053-2a95a90ade8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA204389
- Marketing category
- ANDA
- Marketing start
- 2022-09-26
- 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 |
|---|
| 31722-808-02 | memantine hydrochloride | 200 in 1 BOTTLE | TABLET | 200 | | 1 |
| 31722-808-32 | memantine hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | | 1 |
| 31722-808-32 | memantine hydrochloride | 10 in 1 CARTON | TABLET | 10 | | 1 |
| 31722-808-60 | memantine hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-808 | MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE) TABLET [CAMBER PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 4 package rows | 20221012_910827aa-5320-446c-8f66-3f17c0ee36d9.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 |
|---|
| 31722-808-02 | 31722080802 | 200 TABLET in 1 BOTTLE (31722-808-02) | 200 tablet | 2022-09-26 | 0000-00-00 | No | No | Current |
| 31722-808-32 | 31722080832 | 10 BLISTER PACK in 1 CARTON (31722-808-32) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2022-09-26 | 0000-00-00 | No | No | Current |
| 31722-808-60 | 31722080860 | 60 TABLET in 1 BOTTLE (31722-808-60) | 60 tablet | 2022-09-26 | 0000-00-00 | No | No | Current |