FDA.reportPublic FDA data

Namenda

Product NDC
55289-937
11-digit product format
552890937
Labeler code
55289
Product ID
55289-937_d29462f1-443a-106d-e053-2a95a90ac7d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
NDA021487
Marketing category
NDA
Marketing start
2003-10-16
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55289-937DDiscontinued by firm2026-07-31
excluded packagepackage55289-93755289-937-30DDiscontinued by firm2026-07-31
excluded packagepackage55289-93755289-937-60DDiscontinued 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
55289-937-30EA - Each55289-93751ec02cc-6387-4bba-a114-139e38ea8d5f12012-07-24
55289-937-60EA - Each55289-937414c39e8-d904-475c-bc70-9084f351952312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]6
MEMANTINEACTIVE MOIETYW8O17SJF3TNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-937-305528909373030 TABLET in 1 BOTTLE, PLASTIC (55289-937-30) 30 tablet2015-11-050000-00-00NoNoCurrent
55289-937-605528909376060 TABLET in 1 BOTTLE, PLASTIC (55289-937-60) 60 tablet2015-11-050000-00-00NoNoCurrent