FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
62135-943
11-digit product format
621350943
Labeler code
62135
Product ID
62135-943_499eab19-cf6f-dfcd-e063-6294a90acc1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA204033
Marketing category
ANDA
Marketing start
2015-10-13
Substance
MEMANTINE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204033-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE2MG/MLSOLUTION / ORALAARS2015-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204033-001AA

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 22:54:322026-06A204033-001MEMANTINE HYDROCHLORIDE2MG/MLSOLUTION / ORALAARS2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204033-001AA1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.d1f97615-e888-421e-b50a-95a87a1965ff2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204033
application number: ANDA204033
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEChartwell RX, LLCa7b76864-6de7-45f6-be5b-5ecfca8116272026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204033
application number: ANDA204033
ndc (product): 62135-943

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE2 mg/mL

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
996740Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a7b76864-6de7-45f6-be5b-5ecfca811627Available 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
62135-943-05Memantine Hydrochloride5 mL in 1 CUPSOLUTION54
62135-943-24Memantine Hydrochloride10 in 1 TRAYSOLUTION104
62135-943-24Memantine Hydrochloride2 in 1 BOXSOLUTION24
62135-943-37Memantine Hydrochloride240 mL in 1 BOTTLESOLUTION2404

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-943-05ML - Milliliter62135-9434ba1001c-8bd0-40f3-8848-aa1805c5571912025-05-14
62135-943-24ML - Milliliter62135-94381a89476-e919-40b0-aba1-b51335c7559e12025-05-14
62135-943-37ML - Milliliter62135-943b0cf661c-6b05-4f75-b113-72f67b24d1d412022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-943MEMANTINE HYDROCHLORIDE SOLUTION [CHARTWELL RX, LLC]3Current NDC, Legacy NDC, 4 package rows20250306_a7b76864-6de7-45f6-be5b-5ecfca811627.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996740memantine HCl 2 MG in 1 mL Oral SolutionPSNa7b76864-6de7-45f6-be5b-5ecfca8116274
996740memantine hydrochloride 2 MG/ML Oral SolutionSCDa7b76864-6de7-45f6-be5b-5ecfca8116274
996740memantine HCl 10 MG per 5 ML Oral SolutionSYa7b76864-6de7-45f6-be5b-5ecfca8116274
996740memantine HCl 2 MG per 1 ML Oral SolutionSYa7b76864-6de7-45f6-be5b-5ecfca8116274

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62135-943-05621350943055 mL in 1 CUP5 mlHistorical
62135-943-24621350943242 TRAY in 1 BOX (62135-943-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (62135-943-05) 2 tray2025-02-25NoNoCurrent
62135-943-3762135094337240 mL in 1 BOTTLE (62135-943-37) 240 ml2022-10-270000-00-00NoNoCurrent