Memantine Hydrochloride
- Product NDC
- 65862-652
- 11-digit product format
- 658620652
- Labeler code
- 65862
- Product ID
- 65862-652_12f3b127-625b-4c19-99f5-54f0ddc5cdc0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA203175
- 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 |
|---|
| 65862-652-03 | Memantine Hydrochloride | 3 in 1 CARTON | TABLET, FILM COATED | 3 | | 9 |
| 65862-652-10 | Memantine Hydrochloride | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 9 |
| 65862-652-60 | Memantine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 9 |
| 65862-652-78 | Memantine Hydrochloride | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 9 |
| 65862-652-99 | Memantine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MEMANTINE HYDROCHLORIDE | ACTIVE INGREDIENT | JY0WD0UA60 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| MEMANTINE | ACTIVE MOIETY | W8O17SJF3T | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| POLYETHYLENE GLYCOL 6000 | INACTIVE INGREDIENT | 30IQX730WE | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| SODIUM STEARYL FUMARATE | INACTIVE INGREDIENT | 7CV7WJK4UI | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-652 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 9 | Current NDC, Legacy NDC, 5 package rows | 20221109_ceb733fa-4526-4b76-ab6a-bd4c5638afff.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 |
|---|
| 65862-652-03 | 65862065203 | 3 BLISTER PACK in 1 CARTON (65862-652-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-652-10) | 3 blister pack | 2015-10-13 | 0000-00-00 | No | No | Current |
| 65862-652-10 | 65862065210 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 65862-652-49 | 65862065249 | 4000 TABLET, FILM COATED in 1 BAG (65862-652-49) | | 13-OCT-15 | | | | Current |
| 65862-652-60 | 65862065260 | 60 TABLET, FILM COATED in 1 BOTTLE (65862-652-60) | | 2015-10-13 | 0000-00-00 | No | No | Current |
| 65862-652-78 | 65862065278 | 10 BLISTER PACK in 1 CARTON (65862-652-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (65862-652-10) | 10 blister pack | 2015-10-13 | 0000-00-00 | No | No | Current |
| 65862-652-99 | 65862065299 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-652-99) | | 2015-10-13 | 0000-00-00 | No | No | Current |