Memantine Hydrochloride

Product NDC
50090-4203
11-digit product format
500904203
Labeler code
50090
Product ID
50090-4203_becba3ce-6ddb-43f1-b4dd-5ea6686c45dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090058
Marketing category
ANDA
Marketing start
2015-07-11
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
No
Listing certified through
2021-12-31
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 productproduct50090-4203IInactivated by FDA2026-08-17
excluded packagepackage50090-420350090-4203-0IInactivated 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 · 30 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 packagepackage50090-4203-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-4203-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-4203-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-4203-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-4203-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-4203-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-4203-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-4203-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-4203-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-4203-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-4203-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-4203-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-4203-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-4203-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-4203-01332a3947898…d4bfe170f9cd…

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
A090058-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05
A090058-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090058-001AB
A090058-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-058072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-055c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-055d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-054b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-0574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090058-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090058-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090058-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090058-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090058-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090058-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090058-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090058-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090058-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090058-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090058-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090058-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090058-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090058-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090058-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090058-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090058-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090058-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090058-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090058-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090058-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090058-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090058-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090058-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090058-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090058-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090058-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090058-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090058-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090058-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090058-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090058-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090058-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090058-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090058-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090058-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090058-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090058-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090058-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090058-002AB1bb7c543d1eb4…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4203-0Memantine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4203-0EA - Each50090-42037a9f3c5e-090d-4efb-b0b3-0c57e4ee375f12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4203MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20201117_a2a51c75-d4b2-4735-964c-cb97141edc7a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack2ac7d23c-5f9f-4ffc-ae01-d7099a8a79292024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090058
application number: ANDA090058
Memantine HydrochlorideMEMANTINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.d1963395-3cf7-4433-bf2c-06295bb1c5b02023-10-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090058
application number: ANDA090058

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNa2a51c75-d4b2-4735-964c-cb97141edc7a3
996561memantine hydrochloride 10 MG Oral TabletSCDa2a51c75-d4b2-4735-964c-cb97141edc7a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4203-05009042030090 TABLET, FILM COATED in 1 BOTTLE (50090-4203-0) 2019-03-190000-00-00NoNoCurrent