FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
72578-003
11-digit product format
725780003
Labeler code
72578
Product ID
72578-003_2dee57d8-27d7-481c-b1c9-21375e258a1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA090961
Marketing category
ANDA
Marketing start
2019-02-28
Substance
MEMANTINE HYDROCHLORIDE
Active strength
5 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
A090961-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10
A090961-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090961-001AB
A090961-002AB

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 22:54:322026-06A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10a50c72e98297…
2026-08-01 22:54:322026-06A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090961-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090961-002AB1a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEREMEDYREPACK INC.cbfd9d95-f50b-45ff-9857-9f1712c45e562026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDEDirectRxd0839a2d-35f1-1f14-e053-2995a90ad5492026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3662b11a-354a-b683-e063-6394a90a00862025-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDECoupler LLC2d54be77-75b2-76b3-e063-6294a90a0cc02025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEZydus Lifesciences Limited514421f3-f525-43e8-aecc-8b2bbffd00dc2024-08-16Exact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutionsf05e381f-850d-42ea-9dd8-6d1f8dac4f622024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack0ad2246a-ffa0-43a0-8094-58279d3e3a742024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackbe919d34-e9f4-49c8-8145-2dcafb7cb88c2024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack9cfddd01-6e1d-4ee0-9310-3fb371724e3d2023-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackbf395152-2885-4633-bf3f-2da46e7b79f12023-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack8bd5b908-f46a-4ced-9408-45984d7161492023-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe02023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack54a12ddf-306b-4eb7-a7c3-c7b58df3b3722023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackfac8c59b-5bf5-478e-8223-a5ecaa4006252023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackc8f96b24-de66-4a17-b798-42b42a25e84c2023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEViona Pharmaceuticals Incdcbdb62a-a4e2-4058-b73c-46005f2a5d512022-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (product): 72578-003

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE5 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996561Internal RxNorm lookup
996571Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dcbdb62a-a4e2-4058-b73c-46005f2a5d51Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-003-01Memantine Hydrochloride100 in 1 BOTTLETABLET1003
72578-003-05Memantine Hydrochloride500 in 1 BOTTLETABLET5003
72578-003-10Memantine Hydrochloride1000 in 1 BOTTLETABLET10003
72578-003-14Memantine Hydrochloride60 in 1 BOTTLETABLET603
72578-003-30Memantine Hydrochloride10 in 1 BLISTER PACKTABLET103
72578-003-77Memantine Hydrochloride10 in 1 CARTONTABLET103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-003-05EA - Each72578-003f79da0f8-9c50-4ea5-9b68-363c288fdc8c12019-12-10
72578-003-14EA - Each72578-003ccf1ab2d-7b91-45c0-9d66-315d15cdc96e12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-003MEMANTINE HYDROCHLORIDE TABLET [VIONA PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 6 package rows20221014_dcbdb62a-a4e2-4058-b73c-46005f2a5d51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996571memantine HCl 5 MG Oral TabletPSN9cfddd01-6e1d-4ee0-9310-3fb371724e3d103
996571memantine hydrochloride 5 MG Oral TabletSCD9cfddd01-6e1d-4ee0-9310-3fb371724e3d103
996571memantine HCl 5 MG Oral TabletPSN2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0102
996571memantine HCl 5 MG Oral TabletPSNfac8c59b-5bf5-478e-8223-a5ecaa400625102
996571memantine hydrochloride 5 MG Oral TabletSCD2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe0102
996571memantine hydrochloride 5 MG Oral TabletSCDfac8c59b-5bf5-478e-8223-a5ecaa400625102
996571memantine HCl 5 MG Oral TabletPSN8bd5b908-f46a-4ced-9408-45984d716149101
996571memantine hydrochloride 5 MG Oral TabletSCD8bd5b908-f46a-4ced-9408-45984d716149101
996571memantine HCl 5 MG Oral TabletPSN0ad2246a-ffa0-43a0-8094-58279d3e3a74100
996571memantine hydrochloride 5 MG Oral TabletSCD0ad2246a-ffa0-43a0-8094-58279d3e3a74100
996571memantine HCl 5 MG Oral TabletPSNcbfd9d95-f50b-45ff-9857-9f1712c45e567
996571memantine hydrochloride 5 MG Oral TabletSCDcbfd9d95-f50b-45ff-9857-9f1712c45e567
996571memantine HCl 5 MG Oral TabletPSNf05e381f-850d-42ea-9dd8-6d1f8dac4f626
996571memantine hydrochloride 5 MG Oral TabletSCDf05e381f-850d-42ea-9dd8-6d1f8dac4f626
996571memantine HCl 5 MG Oral TabletPSNd0839a2d-35f1-1f14-e053-2995a90ad5494
996571memantine hydrochloride 5 MG Oral TabletSCDd0839a2d-35f1-1f14-e053-2995a90ad5494
996561memantine HCl 10 MG Oral TabletPSNdcbdb62a-a4e2-4058-b73c-46005f2a5d513
996571memantine HCl 5 MG Oral TabletPSNdcbdb62a-a4e2-4058-b73c-46005f2a5d513
996561memantine hydrochloride 10 MG Oral TabletSCDdcbdb62a-a4e2-4058-b73c-46005f2a5d513
996571memantine hydrochloride 5 MG Oral TabletSCDdcbdb62a-a4e2-4058-b73c-46005f2a5d513
996571memantine HCl 5 MG Oral TabletPSN3662b11a-354a-b683-e063-6394a90a00861
996571memantine HCl 5 MG Oral TabletPSN2d54be77-75b2-76b3-e063-6294a90a0cc01
996571memantine hydrochloride 5 MG Oral TabletSCD3662b11a-354a-b683-e063-6394a90a00861
996571memantine hydrochloride 5 MG Oral TabletSCD2d54be77-75b2-76b3-e063-6294a90a0cc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-003-0172578000301100 TABLET in 1 BOTTLE (72578-003-01) 100 tablet2019-02-280000-00-00NoNoCurrent
72578-003-0572578000305500 TABLET in 1 BOTTLE (72578-003-05) 500 tablet2019-02-280000-00-00NoNoCurrent
72578-003-10725780003101000 TABLET in 1 BOTTLE (72578-003-10) 1000 tablet2019-02-280000-00-00NoNoCurrent
72578-003-147257800031460 TABLET in 1 BOTTLE (72578-003-14) 60 tablet2019-02-280000-00-00NoNoCurrent
72578-003-307257800033010 in 1 BLISTER PACKHistorical
72578-003-777257800037710 BLISTER PACK in 1 CARTON (72578-003-77) / 10 TABLET in 1 BLISTER PACK (72578-003-30) 10 blister pack2019-02-280000-00-00NoNoCurrent