Memantine Hydrochloride

Product NDC
72578-004
11-digit product format
725780004
Labeler code
72578
Product ID
72578-004_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
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
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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10782e0a99824c…
2021-12-28 21:50 UTC2021-12A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090961-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090961-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090961-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090961-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090961-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090961-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090961-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090961-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090961-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090961-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090961-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090961-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090961-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090961-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090961-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090961-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090961-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090961-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090961-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090961-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090961-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090961-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090961-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090961-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090961-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090961-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090961-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090961-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090961-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090961-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090961-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090961-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090961-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090961-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090961-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090961-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090961-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090961-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090961-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090961-002AB1782e0a99824c…

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 · 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
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72578-004-01Memantine Hydrochloride100 in 1 BOTTLETABLET1003
72578-004-05Memantine Hydrochloride500 in 1 BOTTLETABLET5003
72578-004-10Memantine Hydrochloride1000 in 1 BOTTLETABLET10003
72578-004-14Memantine Hydrochloride60 in 1 BOTTLETABLET603
72578-004-30Memantine Hydrochloride10 in 1 BLISTER PACKTABLET103
72578-004-77Memantine Hydrochloride10 in 1 CARTONTABLET103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72578-004-05EA - Each72578-004882d8c46-ddff-475c-adff-4b2b9359aa6612019-12-10
72578-004-14EA - Each72578-0045a3cb444-d2b4-4a4f-a511-d6814ba6e95a12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-004MEMANTINE HYDROCHLORIDE TABLET [VIONA PHARMACEUTICALS INC]3Current NDC, Legacy NDC, 6 package rows20221014_dcbdb62a-a4e2-4058-b73c-46005f2a5d51.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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): 72578-004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN54a12ddf-306b-4eb7-a7c3-c7b58df3b372102
996561memantine HCl 10 MG Oral TabletPSNc8f96b24-de66-4a17-b798-42b42a25e84c102
996561memantine hydrochloride 10 MG Oral TabletSCD54a12ddf-306b-4eb7-a7c3-c7b58df3b372102
996561memantine hydrochloride 10 MG Oral TabletSCDc8f96b24-de66-4a17-b798-42b42a25e84c102
996561memantine HCl 10 MG Oral TabletPSNbe919d34-e9f4-49c8-8145-2dcafb7cb88c100
996561memantine hydrochloride 10 MG Oral TabletSCDbe919d34-e9f4-49c8-8145-2dcafb7cb88c100
996561memantine HCl 10 MG Oral TabletPSNbf395152-2885-4633-bf3f-2da46e7b79f14
996561memantine hydrochloride 10 MG Oral TabletSCDbf395152-2885-4633-bf3f-2da46e7b79f14
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72578-004-0172578000401100 TABLET in 1 BOTTLE (72578-004-01) 100 tablet2019-02-280000-00-00NoNoCurrent
72578-004-0572578000405500 TABLET in 1 BOTTLE (72578-004-05) 500 tablet2019-02-280000-00-00NoNoCurrent
72578-004-10725780004101000 TABLET in 1 BOTTLE (72578-004-10) 1000 tablet2019-02-280000-00-00NoNoCurrent
72578-004-147257800041460 TABLET in 1 BOTTLE (72578-004-14) 60 tablet2019-02-280000-00-00NoNoCurrent
72578-004-307257800043010 in 1 BLISTER PACKHistorical
72578-004-777257800047710 BLISTER PACK in 1 CARTON (72578-004-77) / 10 TABLET in 1 BLISTER PACK (72578-004-30) 10 blister pack2019-02-280000-00-00NoNoCurrent