FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
71335-0346
Requested package NDC
71335-0346-2
11-digit product format
713350346
Labeler code
71335
Product ID
71335-0346_1183728c-e0ed-4c18-b157-071d94d2c38a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206528
Marketing category
ANDA
Marketing start
2015-08-27
Marketing end
0000-00-00
Substance
MEMANTINE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage71335-034671335-0346-2DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206528-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30
A206528-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206528-001AB
A206528-002AB

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 22:54:322026-06A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30a50c72e98297…
2026-08-01 22:54:322026-06A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206528-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206528-002AB1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.becb09dc-174d-4817-88d4-f38c8adcd3092026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackafc07196-be28-4521-afc0-d4aa5b6fd46d2026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAjanta Pharma USA Inc.292671f2-f221-4a3d-a110-a266a9527e042025-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC30b8b982-db74-7cf4-e063-6394a90a3a6b2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HCLMEMANTINE HCLDirect_Rx1289db0e-5179-d157-e063-6294a90ab7582024-02-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutionsd1c2ec99-7183-46e3-a96e-4f23e20b8b062023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0346-27133503460228 TABLET in 1 BOTTLE (71335-0346-2) 28 tablet2021-12-270000-00-00NoNoCurrent