Namenda

Product NDC
67046-489
11-digit product format
670460489
Labeler code
67046
Product ID
67046-489_bc6e059d-1951-4fa3-b904-230d4165724d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
NDA021487
Marketing category
NDA
Marketing start
2010-03-19
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67046-489IInactivated by FDA2026-08-17
excluded packagepackage67046-48967046-489-60IInactivated by FDA2026-08-17

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67046-489-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67046-489-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67046-489-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67046-489-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67046-489-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67046-489-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67046-489-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67046-489-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67046-489-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67046-489-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67046-489-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67046-489-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67046-489-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67046-489-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67046-489-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage67046-489-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage67046-489-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage67046-489-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage67046-489-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage67046-489-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage67046-489-609bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67046-489-60110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021487-001NAMENDAMEMANTINE HYDROCHLORIDE5MGTABLET / ORALRLD2003-10-16
N021487-002NAMENDAMEMANTINE HYDROCHLORIDE10MGTABLET / ORALRLD2003-10-16

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021487-001NAMENDA5MGTABLET / ORALRLD2003-10-16caaa826d4ba7…
2026-08-18 06:07:402026-07N021487-002NAMENDA10MGTABLET / ORALRLD2003-10-16caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-165c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-165d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-164b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-1674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021487-001NAMENDA5MGTABLET / ORALABRLD2003-10-16bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021487-002NAMENDA10MGTABLET / ORALABRLD, RS2003-10-16bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021487-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021487-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021487-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021487-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021487-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021487-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021487-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021487-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021487-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021487-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021487-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021487-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021487-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021487-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021487-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021487-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021487-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021487-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021487-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021487-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021487-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021487-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021487-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021487-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021487-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021487-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021487-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021487-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021487-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021487-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021487-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021487-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021487-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021487-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021487-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021487-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021487-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021487-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021487-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021487-002AB1782e0a99824c…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-489-602019-10-21C16284748780-1956f9ecf-bc58-621f-e053-dbdaa90a74adbc6e059d-1951-4fa3-b904-230d4165724d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-489-60Namenda60 in 1 BLISTER PACKTABLET601

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-489NAMENDA (MEMANTINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20100322_bc6e059d-1951-4fa3-b904-230d4165724d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
memantine hydrochlorideMEMANTINE HYDROCHLORIDECardinal Health 107, LLCe5754973-e73b-4a25-abb4-80f91880f0182026-06-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021487
application number: NDA021487
memantine hydrochlorideMEMANTINE HYDROCHLORIDEActavis Pharma, Inc.72973b46-f307-4a9e-8fb1-ad2cbccfd7362018-11-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 021487
application number: NDA021487
memantine hydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCc8f5c20b-4573-44c5-89fc-4da11b2e1fe12017-11-30Warnings, Adverse reactionsExact identifier
application applno (NDA): 021487
application number: NDA021487

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNbc6e059d-1951-4fa3-b904-230d4165724d1
996563Namenda 10 MG Oral TabletPSNbc6e059d-1951-4fa3-b904-230d4165724d1
996563memantine hydrochloride 10 MG Oral Tablet [Namenda]SBDbc6e059d-1951-4fa3-b904-230d4165724d1
996561memantine hydrochloride 10 MG Oral TabletSCDbc6e059d-1951-4fa3-b904-230d4165724d1
996563Namenda 10 MG Oral TabletSYbc6e059d-1951-4fa3-b904-230d4165724d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-489-606704604896060 in 1 BLISTER PACKHistorical