Memantine Hydrochloride

Product NDC
29300-172
11-digit product format
293000172
Labeler code
29300
Product ID
29300-172_16cd3370-8ddc-4dbb-82b3-98e128fb3482
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA200022
Marketing category
ANDA
Marketing start
2015-11-01
Substance
MEMANTINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A200022-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13
A200022-002MEMANTINE 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
A200022-001AB
A200022-002AB

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 UTC2026-02A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-138072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-135c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-135d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-134b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-1374a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200022-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200022-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13782e0a99824c…
2021-12-28 21:50 UTC2021-12A200022-002MEMANTINE 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 UTC2026-02A200022-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200022-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200022-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200022-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200022-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200022-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200022-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200022-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200022-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200022-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200022-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200022-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200022-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200022-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200022-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200022-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200022-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200022-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200022-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200022-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200022-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200022-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200022-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200022-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200022-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200022-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200022-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A200022-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200022-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200022-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200022-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A200022-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200022-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A200022-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200022-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A200022-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200022-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A200022-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200022-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A200022-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE10 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996561Internal RxNorm lookup
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
ff74edcb-d7ed-4b70-8f22-4cb5ccc58f90Available 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29300-172-05Memantine Hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5005
29300-172-16Memantine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-172-05EA - Each29300-172db90f4e1-1999-423e-9677-ca79f144ee4912015-11-12
29300-172-16EA - Each29300-172ab92c8f2-cf29-409d-b15f-9036b51bae3612015-11-12

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-172MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UNICHEM PHARMACEUTICALS (USA), INC.]5Current NDC, Legacy NDC, 2 package rows20201212_ff74edcb-d7ed-4b70-8f22-4cb5ccc58f90.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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC47e4a696-fe2a-c905-e063-6294a90a74152026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200022
application number: ANDA200022
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAvPAK11d27c75-fdc0-f9da-e063-6394a90ac6b02026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200022
application number: ANDA200022
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutionsca619439-f4ca-43f1-9261-9aa2b6dc74502024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200022
application number: ANDA200022
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutions2fdf0b2b-0337-472d-83ec-075c17c9b0d02023-11-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200022
application number: ANDA200022
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.ff74edcb-d7ed-4b70-8f22-4cb5ccc58f902020-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200022
application number: ANDA200022
ndc (product): 29300-172

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSNca619439-f4ca-43f1-9261-9aa2b6dc74509
996561memantine hydrochloride 10 MG Oral TabletSCDca619439-f4ca-43f1-9261-9aa2b6dc74509
996561memantine HCl 10 MG Oral TabletPSN255e52a7-68c2-4f2a-8dc4-46f95d68c5685
996561memantine HCl 10 MG Oral TabletPSNff74edcb-d7ed-4b70-8f22-4cb5ccc58f905
996571memantine HCl 5 MG Oral TabletPSNff74edcb-d7ed-4b70-8f22-4cb5ccc58f905
996561memantine hydrochloride 10 MG Oral TabletSCD255e52a7-68c2-4f2a-8dc4-46f95d68c5685
996561memantine hydrochloride 10 MG Oral TabletSCDff74edcb-d7ed-4b70-8f22-4cb5ccc58f905
996571memantine hydrochloride 5 MG Oral TabletSCDff74edcb-d7ed-4b70-8f22-4cb5ccc58f905
996561memantine HCl 10 MG Oral TabletPSN11d27c75-fdc0-f9da-e063-6394a90ac6b02
996571memantine HCl 5 MG Oral TabletPSN11d27c75-fdc0-f9da-e063-6394a90ac6b02
996561memantine hydrochloride 10 MG Oral TabletSCD11d27c75-fdc0-f9da-e063-6394a90ac6b02
996571memantine hydrochloride 5 MG Oral TabletSCD11d27c75-fdc0-f9da-e063-6394a90ac6b02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-172-0529300017205500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-172-05) 2015-11-010000-00-00NoNoCurrent
29300-172-162930001721660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (29300-172-16) 2015-11-010000-00-00NoNoCurrent