Memantine Hydrochloride
- Product NDC
- 0832-1112
- 11-digit product format
- 008321112
- Labeler code
- 0832
- Product ID
- 0832-1112_45af280b-1724-c805-e063-6294a90a76ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Memantine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Upsher-Smith Laboratories, LLC
- Application
- ANDA090043
- Marketing category
- ANDA
- Marketing start
- 2015-07-31
- Marketing end
- 2028-01-31
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Memantine Hydrochloride
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 |
|---|
| 0832-1112-60 | Memantine Hydrochloride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 10 |
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 [UPSHER-SMITH LABORATORIES, INC] | 1 | |
| memantine | ACTIVE MOIETY | W8O17SJF3T | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] | 1 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] | 1 | |
| ferrosoferric oxide | INACTIVE INGREDIENT | XM0M87F357 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] | 1 | |
| polyethylene glycols | INACTIVE INGREDIENT | 3WJQ0SDW1A | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] | 1 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0832-1112 | MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20230324_6e0ade9e-b721-4701-bcb7-de464e19e707.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 |
|---|
| 0832-1112-60 | 00832111260 | 60 TABLET, FILM COATED in 1 BOTTLE (0832-1112-60) | 2015-07-31 | 2028-01-31 | No | No | Current |