FDA.reportPublic FDA data

Memantine Hydrochloride

Product NDC
47335-322
11-digit product format
473350322
Labeler code
47335
Product ID
47335-322_81ca8cbf-7854-43a2-bd0b-1dbaf4709a42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Memantine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
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
Memantine HydrochlorideMEMANTINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.d1963395-3cf7-4433-bf2c-06295bb1c5b02023-10-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090058
application number: ANDA090058
ndc (product): 47335-322

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996561Internal RxNorm lookup
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
d1963395-3cf7-4433-bf2c-06295bb1c5b0Available 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
47335-322-08Memantine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10013
47335-322-13Memantine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED50013
47335-322-18Memantine Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED100013
47335-322-83Memantine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3013
47335-322-86Memantine Hydrochloride60 in 1 BOTTLETABLET, FILM COATED6013
47335-322-88Memantine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-322-13EA - Each47335-322d482c0fd-95bf-4460-aac5-aa76ed2b245c12015-08-04
47335-322-86EA - Each47335-3222e488b96-af16-4922-a3a9-1579437501db12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MEMANTINE HYDROCHLORIDEACTIVE INGREDIENTJY0WD0UA60MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
MEMANTINEACTIVE MOIETYW8O17SJF3TMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
TALCINACTIVE INGREDIENT7SEV7J4R1UMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-322MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]13Current NDC, Legacy NDC, 6 package rows20231006_d1963395-3cf7-4433-bf2c-06295bb1c5b0.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
996561memantine HCl 10 MG Oral TabletPSNd1963395-3cf7-4433-bf2c-06295bb1c5b013
996571memantine HCl 5 MG Oral TabletPSNd1963395-3cf7-4433-bf2c-06295bb1c5b013
996561memantine hydrochloride 10 MG Oral TabletSCDd1963395-3cf7-4433-bf2c-06295bb1c5b013
996571memantine hydrochloride 5 MG Oral TabletSCDd1963395-3cf7-4433-bf2c-06295bb1c5b013
996561memantine HCl 10 MG Oral TabletPSNa2a51c75-d4b2-4735-964c-cb97141edc7a3
996561memantine hydrochloride 10 MG Oral TabletSCDa2a51c75-d4b2-4735-964c-cb97141edc7a3
996561memantine HCl 10 MG Oral TabletPSN5a455264-1054-2ddb-e053-2991aa0a66b01
996561memantine hydrochloride 10 MG Oral TabletSCD5a455264-1054-2ddb-e053-2991aa0a66b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-322-0847335032208100 TABLET, FILM COATED in 1 BOTTLE (47335-322-08) 2015-07-110000-00-00NoNoCurrent
47335-322-1347335032213500 TABLET, FILM COATED in 1 BOTTLE (47335-322-13) 2015-07-110000-00-00NoNoCurrent
47335-322-18473350322181000 TABLET, FILM COATED in 1 BOTTLE (47335-322-18) 2015-07-110000-00-00NoNoCurrent
47335-322-834733503228330 TABLET, FILM COATED in 1 BOTTLE (47335-322-83) 2015-07-110000-00-00NoNoCurrent
47335-322-864733503228660 TABLET, FILM COATED in 1 BOTTLE (47335-322-86) 2015-07-110000-00-00NoNoCurrent
47335-322-8847335032288100 TABLET, FILM COATED in 1 BOTTLE (47335-322-88) 2015-07-110000-00-00NoNoCurrent