FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
67046-1471
Requested package NDC
67046-1471-3
11-digit product format
670461471
Labeler code
67046
Product ID
67046-1471_2d54b58a-d1dc-e87f-e063-6394a90ab92e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA090961
Marketing category
ANDA
Marketing start
2025-02-04
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
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
A090961-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10
A090961-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090961-001AB
A090961-002AB

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 22:54:322026-06A090961-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2017-07-10a50c72e98297…
2026-08-01 22:54:322026-06A090961-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2017-07-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090961-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090961-002AB1a50c72e98297…

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEREMEDYREPACK INC.cbfd9d95-f50b-45ff-9857-9f1712c45e562026-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDEDirectRxd0839a2d-35f1-1f14-e053-2995a90ad5492026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3662b11a-354a-b683-e063-6394a90a00862025-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDECoupler LLC2d54be77-75b2-76b3-e063-6294a90a0cc02025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
ndc (package): 67046-1471-3
ndc (product): 67046-1471
ndc11 (package): 67046147103
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEZydus Lifesciences Limited514421f3-f525-43e8-aecc-8b2bbffd00dc2024-08-16Exact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutionsf05e381f-850d-42ea-9dd8-6d1f8dac4f622024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack0ad2246a-ffa0-43a0-8094-58279d3e3a742024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackbe919d34-e9f4-49c8-8145-2dcafb7cb88c2024-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack9cfddd01-6e1d-4ee0-9310-3fb371724e3d2023-10-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackbf395152-2885-4633-bf3f-2da46e7b79f12023-03-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack8bd5b908-f46a-4ced-9408-45984d7161492023-03-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe02023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack54a12ddf-306b-4eb7-a7c3-c7b58df3b3722023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackfac8c59b-5bf5-478e-8223-a5ecaa4006252023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackc8f96b24-de66-4a17-b798-42b42a25e84c2023-03-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEViona Pharmaceuticals Incdcbdb62a-a4e2-4058-b73c-46005f2a5d512022-10-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090961
application number: ANDA090961

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MEMANTINE HYDROCHLORIDE5 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
996571Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d54be77-75b2-76b3-e063-6294a90a0cc0Available 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
67046-1471-3Memantine Hydrochloride30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1471MEMANTINE HYDROCHLORIDE TABLET [COUPLER LLC]1Current NDC, 1 package rows20250206_2d54be77-75b2-76b3-e063-6294a90a0cc0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996571memantine HCl 5 MG Oral TabletPSN2d54be77-75b2-76b3-e063-6294a90a0cc01
996571memantine hydrochloride 5 MG Oral TabletSCD2d54be77-75b2-76b3-e063-6294a90a0cc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1471-36704614710330 TABLET in 1 BLISTER PACK (67046-1471-3) 30 tablet2025-02-04NoNoCurrent