memantine hydrochloride
- Product NDC
- 0591-3875
- 11-digit product format
- 005913875
- Labeler code
- 0591
- Product ID
- 0591-3875_985e1190-b8a0-4775-9a20-ad1924b14fb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- memantine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- NDA021487
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2015-04-01
- Marketing end
- 2028-02-29
- 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
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- memantine hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MEMANTINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JY0WD0UA60 |
| Rxcui | 996561, 996571, 996572 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-3875-44 | memantine hydrochloride | 10 in 1 BOX, UNIT-DOSE | TABLET | 10 | | 10 |
| 0591-3875-45 | memantine hydrochloride | 10 in 1 BLISTER PACK | TABLET | 10 | | 10 |
| 0591-3875-60 | memantine hydrochloride | 60 in 1 BOTTLE | TABLET | 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 MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| memantine | ACTIVE MOIETY | W8O17SJF3T | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| cellulose, microcrystalline | INACTIVE INGREDIENT | OP1R32D61U | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| FD&C blue No. 2 | INACTIVE INGREDIENT | L06K8R7DQK | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| ferrosoferric oxide | INACTIVE INGREDIENT | XM0M87F357 | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| hypromelloses | INACTIVE INGREDIENT | 3NXW29V3WO | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| polyethylene glycol 400 | INACTIVE INGREDIENT | B697894SGQ | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-3875 | MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20240509_72973b46-f307-4a9e-8fb1-ad2cbccfd736.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 |
|---|
| 0591-3875-44 | 00591387544 | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0591-3875-44) / 10 TABLET in 1 BLISTER PACK (0591-3875-45) | 10 blister pack | 2015-04-01 | 2027-07-31 | No | No | Current |
| 0591-3875-45 | 00591387545 | 10 in 1 BLISTER PACK | | | | | | Historical |
| 0591-3875-60 | 00591387560 | 60 TABLET in 1 BOTTLE (0591-3875-60) | 60 tablet | 2015-04-01 | 2028-02-29 | No | No | Current |