memantine hydrochloride

Product NDC
0904-6737
11-digit product format
009046737
Labeler code
0904
Product ID
0904-6737_cbe75266-38f8-452f-82aa-38409630ff71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA206028
Marketing category
ANDA
Marketing start
2018-02-20
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
21 mg/1
Pharmacologic classes
NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct0904-6737DDiscontinued by firm2026-08-03
excluded packagepackage0904-67370904-6737-61DDiscontinued 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 · 8 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
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct0904-6737DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-67370904-6737-61DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0904-6737DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-67370904-6737-61DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct0904-6737DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-67370904-6737-61DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct0904-6737DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-67370904-6737-61DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206028-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28
A206028-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28
A206028-003MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28
A206028-004MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A206028-001AB
A206028-002AB
A206028-003AB
A206028-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206028-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206028-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206028-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206028-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206028-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206028-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206028-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206028-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206028-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A206028-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206028-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206028-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206028-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206028-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206028-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206028-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206028-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206028-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206028-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206028-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206028-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206028-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206028-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206028-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206028-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206028-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206028-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206028-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206028-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206028-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206028-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206028-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206028-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206028-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206028-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206028-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206028-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206028-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206028-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206028-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206028-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206028-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206028-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206028-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206028-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206028-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206028-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206028-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206028-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206028-004AB1d06236e962d9…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
memantine hydrochlorideMEMANTINE HYDROCHLORIDELupin Pharmaceuticals, Inc.24290655-47f3-4042-a977-a832c5161d2c2026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206028
application number: ANDA206028
memantine hydrochlorideMEMANTINE HYDROCHLORIDEMajor Pharmaceuticalsf6ce7cca-d245-44f2-986c-2a8d85dbb5fb2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206028
application number: ANDA206028
ndc (product): 0904-6737

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
0904-6737-61memantine hydrochloride100 in 1 CARTONCAPSULE, EXTENDED RELEASE1006
0904-6737-61memantine hydrochloride1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6737-61EA - Each0904-673710fb335f-b56f-4af9-8856-7fe548d3634b12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6737MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]5Legacy NDC, 2 package rows20250418_f6ce7cca-d245-44f2-986c-2a8d85dbb5fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996594memantine HCl 14 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996603memantine HCl 21 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996615memantine HCl 7 MG 24HR Extended Release Oral CapsulePSNf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99659424 HR memantine hydrochloride 14 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99660324 HR memantine hydrochloride 21 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
99661524 HR memantine hydrochloride 7 MG Extended Release Oral CapsuleSCDf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996594memantine hydrochloride 14 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996603memantine hydrochloride 21 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6
996615memantine hydrochloride 7 MG 24 HR Extended Release Oral CapsuleSYf6ce7cca-d245-44f2-986c-2a8d85dbb5fb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6737-6100904673761100 BLISTER PACK in 1 CARTON (0904-6737-61) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK100 blister pack2018-02-200000-00-00NoNoCurrent