Memantine Hydrochloride

Product NDC
63629-7154
11-digit product format
636297154
Labeler code
63629
Product ID
63629-7154_1c090e20-f5d1-4ebd-9f9b-667cc15df778
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203175
Marketing category
ANDA
Marketing start
2015-10-13
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#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-7154DDiscontinued by firm2026-08-03
excluded packagepackage63629-715463629-7154-1DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 26 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct63629-7154DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-715463629-7154-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct63629-7154DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-715463629-7154-1DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct63629-7154DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-715463629-7154-1DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct63629-7154DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-715463629-7154-1DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct63629-7154DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-715463629-7154-1DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct63629-7154DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-715463629-7154-1DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct63629-7154DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-715463629-7154-1DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct63629-7154DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-715463629-7154-1DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct63629-7154DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-715463629-7154-1DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct63629-7154DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-715463629-7154-1DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct63629-7154DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-715463629-7154-1DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct63629-7154DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-715463629-7154-1DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct63629-7154IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-715463629-7154-1IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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
A203175-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13
A203175-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203175-001AB
A203175-002AB

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 UTC2026-02A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203175-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A203175-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13782e0a99824c…

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 UTC2026-02A203175-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203175-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203175-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203175-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203175-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203175-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203175-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203175-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203175-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203175-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203175-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203175-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203175-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203175-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203175-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203175-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203175-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203175-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203175-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203175-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203175-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203175-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203175-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203175-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203175-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203175-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203175-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203175-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203175-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203175-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203175-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203175-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203175-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203175-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203175-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203175-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203175-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203175-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203175-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A203175-002AB1782e0a99824c…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAurobindo Pharma Limitedceb733fa-4526-4b76-ab6a-bd4c5638afff2022-11-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203175
application number: ANDA203175

FDA-Initiated Inactive NDC Indexing#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7154-16362971540130 TABLET, FILM COATED in 1 BOTTLE (63629-7154-1) 2016-12-080000-00-00NoNoCurrent