FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
71335-1908
11-digit product format
713351908
Labeler code
71335
Product ID
71335-1908_417d1056-9d1c-47c4-a065-ca8bd6397982
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090058
Marketing category
ANDA
Marketing start
2015-07-11
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
A090058-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05
A090058-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090058-001AB
A090058-002AB

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 22:54:322026-06A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05a50c72e98297…
2026-08-01 22:54:322026-06A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090058-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090058-002AB1a50c72e98297…

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 HYDROCHLORIDEBryant Ranch Prepack2ac7d23c-5f9f-4ffc-ae01-d7099a8a79292024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090058
application number: ANDA090058
ndc (product): 71335-1908
Memantine HydrochlorideMEMANTINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.d1963395-3cf7-4433-bf2c-06295bb1c5b02023-10-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090058
application number: ANDA090058

Additional Listing Data#

Finished product
Yes
Brand name base
Memantine Hydrochloride
Listing expiration
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996561Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ac7d23c-5f9f-4ffc-ae01-d7099a8a7929Available 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
71335-1908-1Memantine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED30102
71335-1908-2Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED60102
71335-1908-3Memantine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED90102
71335-1908-4Memantine Hydrochloride180 in 1 BOTTLETABLET, FILM COATED180102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1908-1EA - Each71335-190802ce7c89-1e51-4986-af2f-cb3b81b9519f12022-06-06
71335-1908-2EA - Each71335-1908434bda10-980a-42a9-bb5e-1ba9a0ee335712022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1908MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 4 package rows20240509_2ac7d23c-5f9f-4ffc-ae01-d7099a8a7929.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996561memantine HCl 10 MG Oral TabletPSN2ac7d23c-5f9f-4ffc-ae01-d7099a8a7929102
996561memantine hydrochloride 10 MG Oral TabletSCD2ac7d23c-5f9f-4ffc-ae01-d7099a8a7929102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1908-17133519080130 TABLET, FILM COATED in 1 BOTTLE (71335-1908-1) 2021-07-150000-00-00NoNoCurrent
71335-1908-27133519080260 TABLET, FILM COATED in 1 BOTTLE (71335-1908-2) 2021-07-150000-00-00NoNoCurrent
71335-1908-37133519080390 TABLET, FILM COATED in 1 BOTTLE (71335-1908-3) 2021-07-150000-00-00NoNoCurrent
71335-1908-471335190804180 TABLET, FILM COATED in 1 BOTTLE (71335-1908-4) 2021-07-150000-00-00NoNoCurrent