Namenda

Product NDC
0456-3414
11-digit product format
004563414
Labeler code
0456
Product ID
0456-3414_cd1a8e3a-dc26-4e3a-8840-30b67bbadff6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA022525
Marketing category
NDA
Marketing start
2011-10-31
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
14 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94db636e-a074-45fd-8e8d-331920a99436Product name420250103
941773f8-a40e-0684-da08-ff9a143e6368Product name720231219
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-3414-11EA - Each0456-341405c231ba-c4f1-4c9b-9412-23a328f3a70412015-07-20
0456-3414-33EA - Each0456-341488df2e95-11a8-4f04-8577-fa48d6d2208312013-05-02
0456-3414-63EA - Each0456-3414af0068ce-1fea-4c10-b6d3-1e13ad3a40a612013-05-02
0456-3414-90EA - Each0456-341451f810d4-6cdb-4738-a359-be8a54633a3812013-05-02

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
0456-3414NAMENDA XR (MEMANTINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE NAMENDA XR (MEMANTINE HYDROCHLORIDE) KIT [ALLERGAN, INC.]18Legacy NDC20241006_710f523f-0158-4639-8ce7-57598247d48c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSN1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSN1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996597Namenda XR 14 MG 24HR Extended Release Oral CapsulePSN1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996611Namenda XR 28 MG 24HR Extended Release Oral CapsulePSN1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
99659724 HR memantine hydrochloride 14 MG Extended Release Oral Capsule [Namenda]SBD1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
99661124 HR memantine hydrochloride 28 MG Extended Release Oral Capsule [Namenda]SBD1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCD1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCD1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
99659724 HR Namenda 14 MG Extended Release Oral CapsuleSY1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
99661124 HR Namenda 28 MG Extended Release Oral CapsuleSY1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSY1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSY1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996597Namenda XR 14 MG 24 HR Extended Release Oral CapsuleSY1fa2b7bc-94e5-4566-a7c5-419f8fd393a76
996611Namenda XR 28 MG 24 HR Extended Release Oral CapsuleSY1fa2b7bc-94e5-4566-a7c5-419f8fd393a76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0456-3414-330045634143330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0456-3414-33) 2011-10-310000-00-00NoNoCurrent
0456-3414-900045634149090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0456-3414-90) 2011-10-310000-00-00NoNoCurrent