FDA.reportPublic FDA data

Namenda

Product NDC
63629-3383
11-digit product format
636293383
Labeler code
63629
Product ID
63629-3383_650922c0-282d-489d-8718-4c9c001d0ac4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021487
Marketing category
NDA
Marketing start
2003-10-16
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-3383DDiscontinued by firm2026-07-31
excluded packagepackage63629-338363629-3383-1DDiscontinued by firm2026-07-31
excluded packagepackage63629-338363629-3383-2DDiscontinued by firm2026-07-31
excluded packagepackage63629-338363629-3383-3DDiscontinued by firm2026-07-31
excluded packagepackage63629-338363629-3383-4DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021487-001NAMENDAMEMANTINE HYDROCHLORIDE5MGTABLET / ORALRLD2003-10-16
N021487-002NAMENDAMEMANTINE HYDROCHLORIDE10MGTABLET / ORALRLD2003-10-16

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 22:54:322026-06N021487-001NAMENDA5MGTABLET / ORALRLD2003-10-16a50c72e98297…
2026-08-01 22:54:322026-06N021487-002NAMENDA10MGTABLET / ORALRLD2003-10-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
memantine hydrochlorideMEMANTINE HYDROCHLORIDECardinal Health 107, LLCe5754973-e73b-4a25-abb4-80f91880f0182026-06-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021487
application number: NDA021487
memantine hydrochlorideMEMANTINE HYDROCHLORIDEActavis Pharma, Inc.72973b46-f307-4a9e-8fb1-ad2cbccfd7362018-11-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021487
application number: NDA021487
memantine hydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc8f5c20b-4573-44c5-89fc-4da11b2e1fe12017-11-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 021487
application number: NDA021487

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3383-1EA - Each63629-338382a994c3-0be2-423d-99fc-2cf2d099976112013-02-13
63629-3383-2EA - Each63629-33831a8f1de9-cf00-4ce9-9906-4c0c05d7989212013-02-13
63629-3383-3EA - Each63629-338344d82a95-c66e-47ae-af44-53b030a371a512013-02-13
63629-3383-4EA - Each63629-338373c5c444-c7d9-45bc-9ab7-0dd90f9a90e312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1000
MEMANTINEACTIVE MOIETYW8O17SJF3TNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1000
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1000