Memantine Hydrochloride
- Product NDC
- 71335-1603
- 11-digit product format
- 713351603
- Labeler code
- 71335
- Product ID
- 71335-1603_7a5a4451-bd05-4f77-9c6c-563119465803
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090961
- Marketing category
- ANDA
- Marketing start
- 2019-02-28
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1603-1 | Memantine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 71335-1603-2 | Memantine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 4 |
| 71335-1603-3 | Memantine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
| 71335-1603-4 | Memantine Hydrochloride | 180 in 1 BOTTLE | TABLET | 180 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1603 | MEMANTINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 4 | Current NDC, Legacy NDC, 4 package rows | 20230401_bf395152-2885-4633-bf3f-2da46e7b79f1.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 |
|---|
| 71335-1603-1 | 71335160301 | 30 TABLET in 1 BOTTLE (71335-1603-1) | 30 tablet | 2020-07-09 | 0000-00-00 | No | No | Current |
| 71335-1603-2 | 71335160302 | 60 TABLET in 1 BOTTLE (71335-1603-2) | 60 tablet | 2020-05-18 | 0000-00-00 | No | No | Current |
| 71335-1603-3 | 71335160303 | 90 TABLET in 1 BOTTLE (71335-1603-3) | 90 tablet | 2020-12-14 | 0000-00-00 | No | No | Current |
| 71335-1603-4 | 71335160304 | 180 TABLET in 1 BOTTLE (71335-1603-4) | 180 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |