Memantine Hydrochloride

Product NDC
0904-6506
11-digit product format
009046506
Labeler code
0904
Product ID
0904-6506_f98561aa-0a02-4e99-bacb-d92c81833bbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA090048
Marketing category
ANDA
Marketing start
2015-07-20
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
A090048-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-14
A090048-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALABRS2010-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090048-001AB
A090048-002AB

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 UTC2026-02A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-148072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-145c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-145d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-144b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-1474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-14bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090048-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-04-14782e0a99824c…
2021-12-28 21:50 UTC2021-12A090048-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-04-14782e0a99824c…

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 UTC2026-02A090048-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090048-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090048-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090048-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090048-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090048-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090048-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090048-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090048-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090048-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090048-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090048-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090048-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090048-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090048-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090048-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090048-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090048-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090048-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090048-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090048-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090048-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090048-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090048-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090048-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090048-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090048-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090048-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090048-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090048-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090048-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090048-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090048-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090048-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090048-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090048-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090048-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090048-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090048-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090048-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2027-12-31

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
d0a5e0fc-04e3-417d-bef3-9b309ff71597Available 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
5b597f00-4538-4686-aa4e-3c60ed3788c8Product name220210511
1836e79a-a4d1-4087-2f2e-f878e8a1fef2Product name920151209

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6506-06Memantine Hydrochloride50 in 1 CARTONTABLET, FILM COATED508
0904-6506-06Memantine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED18
0904-6506-61Memantine Hydrochloride100 in 1 CARTONTABLET, FILM COATED1008
0904-6506-61Memantine Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6506-06EA - Each0904-6506730fc9d9-f940-4c2b-b10e-afa3802d1dde12018-05-09
0904-6506-61EA - Each0904-6506f75fa6b2-b178-433f-b42a-1f301adbddc412015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
POVIDONE K12INACTIVE INGREDIENT333AG72FWJMEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE TABLET [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMANTINE TABLET [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6506MEMANTINE TABLET [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 4 package rows20240724_d0a5e0fc-04e3-417d-bef3-9b309ff71597.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEMajor Pharmaceuticalsd0a5e0fc-04e3-417d-bef3-9b309ff715972026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090048
application number: ANDA090048
ndc (product): 0904-6506
Memantine HydrochlorideMEMANTINE HYDROCHLORIDECardinal Health 107, LLC65c9e7bc-71f0-4113-8de1-4fcaa591735f2026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090048
application number: ANDA090048
MemantineMEMANTINEAmerican Health Packaging304a3059-4f7f-4ec4-839d-86492bb5e07b2025-04-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090048
application number: ANDA090048
MemantineMEMANTINENCS HealthCare of KY, LLC dba Vangard Labsa5dcc0e7-761f-4294-bb48-e5ee4a1e2f672024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090048
application number: ANDA090048
MemantineMEMANTINENCS HealthCare of KY, LLC dba Vangard Labs5c8a168d-aef5-4ac7-b8c1-3812a8c228ab2024-08-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090048
application number: ANDA090048
MemantineMEMANTINENorthStar RxLLC7a40ed9d-8853-b616-ff47-0c7b0fd289592023-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090048
application number: ANDA090048
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEDr. Reddys Laboratories Limiteda71e2482-5266-d03e-8b36-862afe78c9a42019-02-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090048
application number: ANDA090048

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN65c9e7bc-71f0-4113-8de1-4fcaa591735f9
996571memantine HCl 5 MG Oral TabletPSN65c9e7bc-71f0-4113-8de1-4fcaa591735f9
996561memantine hydrochloride 10 MG Oral TabletSCD65c9e7bc-71f0-4113-8de1-4fcaa591735f9
996571memantine hydrochloride 5 MG Oral TabletSCD65c9e7bc-71f0-4113-8de1-4fcaa591735f9
996561memantine HCl 10 MG Oral TabletPSNd0a5e0fc-04e3-417d-bef3-9b309ff715978
996571memantine HCl 5 MG Oral TabletPSNd0a5e0fc-04e3-417d-bef3-9b309ff715978
996561memantine hydrochloride 10 MG Oral TabletSCDd0a5e0fc-04e3-417d-bef3-9b309ff715978
996571memantine hydrochloride 5 MG Oral TabletSCDd0a5e0fc-04e3-417d-bef3-9b309ff715978

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6506-060090465060650 BLISTER PACK in 1 CARTON (0904-6506-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK50 blister pack2015-07-200000-00-00NoNoCurrent
0904-6506-6100904650661100 BLISTER PACK in 1 CARTON (0904-6506-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2015-07-200000-00-00NoNoCurrent