Memantine Hydrochloride
- Product NDC
- 47335-321
- 11-digit product format
- 473350321
- Labeler code
- 47335
- Product ID
- 47335-321_81ca8cbf-7854-43a2-bd0b-1dbaf4709a42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA090058
- Marketing category
- ANDA
- Marketing start
- 2015-07-11
- 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 |
|---|
| 47335-321-08 | Memantine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 13 |
| 47335-321-18 | Memantine Hydrochloride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 13 |
| 47335-321-86 | Memantine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 13 |
| 47335-321-88 | Memantine Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 13 |
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 [SUN PHARMA GLOBAL FZE] | 4 | |
| MEMANTINE | ACTIVE MOIETY | W8O17SJF3T | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-321 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 13 | Current NDC, Legacy NDC, 4 package rows | 20231006_d1963395-3cf7-4433-bf2c-06295bb1c5b0.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 |
|---|
| 47335-321-08 | 47335032108 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-321-08) | 2015-07-11 | 0000-00-00 | No | No | Current |
| 47335-321-18 | 47335032118 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-321-18) | 2015-07-11 | 0000-00-00 | No | No | Current |
| 47335-321-86 | 47335032186 | 60 TABLET, FILM COATED in 1 BOTTLE (47335-321-86) | 2015-07-11 | 0000-00-00 | No | No | Current |
| 47335-321-88 | 47335032188 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-321-88) | 2015-07-11 | 0000-00-00 | No | No | Current |