FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
43353-165
Requested package NDC
43353-165-18
11-digit product format
433530165
Labeler code
43353
Product ID
43353-165_bd5eaa03-d2d2-4af4-855f-a3fa51a58b72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
memantine hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA200891
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage43353-16543353-165-18DDiscontinued by firm2026-07-31

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
A200891-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13
A200891-002MEMANTINE 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
A200891-001AB
A200891-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A200891-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-10-13a50c72e98297…
2026-08-01 22:54:322026-06A200891-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A200891-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A200891-002AB1a50c72e98297…

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 HYDROCHLORIDEAlembic Pharmaceuticals Limitedb86c0f6e-480b-40e7-aa4d-21bd0659101d2023-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200891
application number: ANDA200891
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.af2b73da-1be4-4b7f-929b-acb3b9a10f782021-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200891
application number: ANDA200891

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-165-18EA - Each43353-16504c13742-91c8-4875-be07-315e6055f1fc12016-08-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-165MEMANTINE HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC20171003_7c093eec-e73f-42aa-acef-101e3d6d039e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43353-165-18433530165183000 TABLET, COATED in 1 BOTTLE (43353-165-18) 2016-03-300000-00-00NoNoCurrent