FDA.reportPublic FDA data

Namenda

Product NDC
0456-3421
11-digit product format
004563421
Labeler code
0456
Product ID
0456-3421_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
21 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0456-3421DDiscontinued by firm2026-07-31
excluded packagepackage0456-34210456-3421-33DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022525-001NAMENDA XRMEMANTINE HYDROCHLORIDE7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21
N022525-002NAMENDA XRMEMANTINE HYDROCHLORIDE14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21
N022525-003NAMENDA XRMEMANTINE HYDROCHLORIDE21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21
N022525-004NAMENDA XRMEMANTINE HYDROCHLORIDE28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022525-00180390092029-03-24U-5392011-11-16
N022525-0018039009*PED2029-09-24Pediatric extension
N022525-00280390092029-03-24U-539
N022525-0028039009*PED2029-09-24Pediatric extension
N022525-00380390092029-03-24U-539
N022525-0038039009*PED2029-09-24Pediatric extension
N022525-00480390092029-03-24U-539
N022525-0048039009*PED2029-09-24Pediatric extension

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022525-001NAMENDA XR7MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21a50c72e98297…
2026-08-01 22:54:322026-06N022525-002NAMENDA XR14MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21a50c72e98297…
2026-08-01 22:54:322026-06N022525-003NAMENDA XR21MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21a50c72e98297…
2026-08-01 22:54:322026-06N022525-004NAMENDA XR28MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD2010-06-21a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N022525-00180390092029-03-24U-5392011-11-16a50c72e98297…
2026-08-01 22:54:322026-06N022525-0018039009*PED2029-09-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022525-00280390092029-03-24U-539a50c72e98297…
2026-08-01 22:54:322026-06N022525-0028039009*PED2029-09-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022525-00380390092029-03-24U-539a50c72e98297…
2026-08-01 22:54:322026-06N022525-0038039009*PED2029-09-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022525-00480390092029-03-24U-539a50c72e98297…
2026-08-01 22:54:322026-06N022525-0048039009*PED2029-09-24Pediatric extensiona50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-3421-33EA - Each0456-34217b9c93ad-76f2-4aeb-938b-f4f1cb858db212013-05-02

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
0456-3421NAMENDA 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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0456-3421-330045634213330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0456-3421-33) 2011-10-310000-00-00NoNoCurrent