FDA.reportPublic FDA data

memantine hydrochloride

Product NDC
50090-7356
11-digit product format
500907356
Labeler code
50090
Product ID
50090-7356_a9ad7dd1-8c73-4d5c-b4b1-01f204add717
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204389
Marketing category
ANDA
Marketing start
2022-09-26
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A204389-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2022-09-26
A204389-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2022-09-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A204389-001AB
A204389-002AB

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 22:54:322026-06A204389-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2022-09-26a50c72e98297…
2026-08-01 22:54:322026-06A204389-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2022-09-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204389-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204389-002AB1a50c72e98297…

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 HYDROCHLORIDEA-S Medication Solutions4d48c958-b606-4427-8502-53450718eefb2024-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204389
application number: ANDA204389
memantine hydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutions9b4e3c54-c001-47cc-bc3a-7d4bf25ccfaf2024-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204389
application number: ANDA204389
ndc (product): 50090-7356
memantine hydrochlorideMEMANTINE HYDROCHLORIDECamber Pharmaceuticals, Inc.910827aa-5320-446c-8f66-3f17c0ee36d92022-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204389
application number: ANDA204389

Additional Listing Data#

Finished product
Yes
Brand name base
memantine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JY0WD0UA60Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996561Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b4e3c54-c001-47cc-bc3a-7d4bf25ccfafAvailable on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7356-1memantine hydrochloride60 in 1 BOTTLETABLET601
50090-7356-2memantine hydrochloride180 in 1 BOTTLETABLET1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7356-1EA - Each50090-735607b2a645-2825-4615-b76d-8f2ec5635bb012024-11-05
50090-7356-2EA - Each50090-735633355dd6-57bf-4ef9-aab8-f55d9e6729c712024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7356MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20241023_9b4e3c54-c001-47cc-bc3a-7d4bf25ccfaf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN9b4e3c54-c001-47cc-bc3a-7d4bf25ccfaf1
996561memantine hydrochloride 10 MG Oral TabletSCD9b4e3c54-c001-47cc-bc3a-7d4bf25ccfaf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7356-15009073560160 TABLET in 1 BOTTLE (50090-7356-1) 60 tablet2024-10-17NoNoCurrent
50090-7356-250090735602180 TABLET in 1 BOTTLE (50090-7356-2) 180 tablet2024-10-17NoNoCurrent