Namenda

Product NDC
0456-3400
11-digit product format
004563400
Labeler code
0456
Product ID
0456-3400_d92cc2f1-556c-46b0-afc6-4f0fda0bc85c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
KIT
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA022525
Marketing category
NDA
Marketing start
2011-09-15
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-3400-29EA - Each0456-3400767115e0-02fc-47ec-8e0c-69f9d0ee50c112013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
memantine hydrochlorideACTIVE INGREDIENTJY0WD0UA60NAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]7
memantineACTIVE MOIETYW8O17SJF3TNAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]7
AMMONIAINACTIVE INGREDIENT5138Q19F1XNAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]7
ethylcellulose (100 MPA.S)INACTIVE INGREDIENT47MLB0F1MVNAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]7
hypromellose 2910 (15 MPA.S)INACTIVE INGREDIENT36SFW2JZ0WNAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]7
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQNAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]7
polyethylene glycol 8000INACTIVE INGREDIENTQ662QK8M3BNAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]7
povidone K30INACTIVE INGREDIENTU725QWY32XNAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]7
sucroseINACTIVE INGREDIENTC151H8M554NAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]7
talcINACTIVE INGREDIENT7SEV7J4R1UNAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-3400NAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) KIT [ALLERGAN, INC.]18Legacy NDC20241006_710f523f-0158-4639-8ce7-57598247d48c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0456-3400-29004563400291 KIT in 1 BLISTER PACK (0456-3400-29) 1 kit2011-09-150000-00-00NoNoCurrent