Memantine Hydrochloride

Product NDC
71335-0346
11-digit product format
713350346
Labeler code
71335
Product ID
71335-0346_1183728c-e0ed-4c18-b157-071d94d2c38a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206528
Marketing category
ANDA
Marketing start
2015-08-27
Marketing end
0000-00-00
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
2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0346DDiscontinued by firm2026-08-17
excluded packagepackage71335-034671335-0346-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-034671335-0346-2DDiscontinued by firm2026-08-17

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 · 36 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 packagepackage71335-0346-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0346-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0346-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0346-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0346-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0346-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0346-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0346-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0346-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0346-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0346-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0346-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0346-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0346-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0346-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0346-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-0346-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-0346-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-0346-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-0346-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-0346-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-0346-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0346-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0346-2557ba5c1ecfa…9c80585c8c6e…

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
A206528-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30
A206528-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206528-001AB
A206528-002AB

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 06:07:402026-07A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30caaa826d4ba7…
2026-08-18 06:07:402026-07A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30bb7c543d1eb4…

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 06:07:402026-07A206528-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206528-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206528-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206528-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206528-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206528-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206528-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206528-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206528-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206528-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206528-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206528-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206528-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206528-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206528-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206528-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206528-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206528-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206528-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206528-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206528-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206528-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206528-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206528-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206528-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206528-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206528-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206528-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206528-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206528-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206528-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206528-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206528-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206528-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206528-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206528-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206528-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206528-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206528-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206528-002AB1bb7c543d1eb4…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.becb09dc-174d-4817-88d4-f38c8adcd3092026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackafc07196-be28-4521-afc0-d4aa5b6fd46d2026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAjanta Pharma USA Inc.292671f2-f221-4a3d-a110-a266a9527e042025-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC30b8b982-db74-7cf4-e063-6394a90a3a6b2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HCLMEMANTINE HCLDirect_Rx1289db0e-5179-d157-e063-6294a90ab7582024-02-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutionsd1c2ec99-7183-46e3-a96e-4f23e20b8b062023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0346-17133503460130 TABLET in 1 BOTTLE (71335-0346-1) 30 tablet2017-08-180000-00-00NoNoCurrent
71335-0346-27133503460228 TABLET in 1 BOTTLE (71335-0346-2) 28 tablet2017-08-180000-00-00NoNoCurrent