MEMANTINE HYDROCHLORIDE

Product NDC
72189-294
11-digit product format
721890294
Labeler code
72189
Product ID
72189-294_4c5d26cb-a6bf-015e-e063-6294a90aa662
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MEMANTINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRx
Application
ANDA090961
Marketing category
ANDA
Marketing start
2021-11-11
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
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-294-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage72189-294-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-294-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage72189-294-900efc9e666f02…f202fb6c5f17…

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
2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
d0839a2d-35f1-1f14-e053-2995a90ad549Available 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
72189-294-30MEMANTINE HYDROCHLORIDE30 in 1 BOTTLETABLET304
72189-294-60MEMANTINE HYDROCHLORIDE60 in 1 BOTTLETABLET604
72189-294-90MEMANTINE HYDROCHLORIDE90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-294-30EA - Each72189-2947e37b946-b278-4ad1-9538-4278bc59c05c12021-12-08
72189-294-90EA - Each72189-294eb8f745c-f0c4-4f7a-a8ef-b993c03bff3312021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-294MEMANTINE HYDROCHLORIDE TABLET [DIRECTRX]2Current NDC, Legacy NDC, 3 package rows20250121_d0839a2d-35f1-1f14-e053-2995a90ad549.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-9857-9f1712c45e562026-08-06Warnings, 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
ndc (product): 72189-294
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996571memantine HCl 5 MG Oral TabletPSNd0839a2d-35f1-1f14-e053-2995a90ad5494
996571memantine hydrochloride 5 MG Oral TabletSCDd0839a2d-35f1-1f14-e053-2995a90ad5494

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-294-307218902943030 TABLET in 1 BOTTLE (72189-294-30) 30 tablet2021-11-110000-00-00NoNoCurrent
72189-294-607218902946060 TABLET in 1 BOTTLE (72189-294-60) 60 tablet2021-11-11NoNoCurrent
72189-294-907218902949090 TABLET in 1 BOTTLE (72189-294-90) 90 tablet2021-11-110000-00-00NoNoCurrent