FDA.reportPublic FDA data

memantine hydrochloride

Product NDC
0615-8264
Requested package NDC
0615-8264-39
11-digit product format
006158264
Labeler code
0615
Product ID
0615-8264_194f162d-30bc-420f-85ae-fca98d00705a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA206028
Marketing category
ANDA
Marketing start
2018-02-20
Marketing end
2026-07-31
Substance
MEMANTINE HYDROCHLORIDE
Active strength
28 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0615-82640615-8264-39DDiscontinued by firm2026-08-03

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…
2026-08-01 22:54:322026-06A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…
2026-08-01 22:54:322026-06A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…
2026-08-01 22:54:322026-06A206028-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206028-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206028-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206028-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A206028-004AB1a50c72e98297…

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

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
0615-8264-39memantine hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8264MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]16Current NDC, Legacy NDC, 1 package rows20240807_e2a371f6-8bfe-4049-b9ca-0ab3d726379e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996609memantine HCl 28 MG 24HR Extended Release Oral CapsulePSNe2a371f6-8bfe-4049-b9ca-0ab3d726379e17
99660924 HR memantine hydrochloride 28 MG Extended Release Oral CapsuleSCDe2a371f6-8bfe-4049-b9ca-0ab3d726379e17
996609memantine hydrochloride 28 MG 24 HR Extended Release Oral CapsuleSYe2a371f6-8bfe-4049-b9ca-0ab3d726379e17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8264-390061582643930 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (0615-8264-39) 2019-01-092026-07-31NoNoCurrent