Memantine hydrochloride
- Product NDC
- 53746-173
- 11-digit product format
- 537460173
- Labeler code
- 53746
- Product ID
- 53746-173_cf08de43-a887-40f3-a074-57ecc8d3093a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA090041
- Marketing category
- ANDA
- Marketing start
- 2015-04-30
- 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 |
|---|
| 53746-173-10 | Memantine hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 19 |
| 53746-173-30 | Memantine hydrochloride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 19 |
| 53746-173-60 | Memantine hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MEMANTINE HYDROCHLORIDE | ACTIVE INGREDIENT | JY0WD0UA60 | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| MEMANTINE | ACTIVE MOIETY | W8O17SJF3T | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-173 | MEMANTINE HYDROCHLORIDE (MEMANTINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 19 | Current NDC, Legacy NDC, 3 package rows | 20231128_054069b5-7aac-4106-821f-ebf7fd531b4f.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 |
|---|
| 53746-173-10 | 53746017310 | 1000 TABLET, FILM COATED in 1 BOTTLE (53746-173-10) | 2015-04-30 | 0000-00-00 | No | No | Current |
| 53746-173-30 | 53746017330 | 30 TABLET, FILM COATED in 1 BOTTLE (53746-173-30) | 2015-04-30 | 0000-00-00 | No | No | Current |
| 53746-173-60 | 53746017360 | 60 TABLET, FILM COATED in 1 BOTTLE (53746-173-60) | 2015-04-30 | 0000-00-00 | No | No | Current |