Home NDC 0591-3875 memantine hydrochloride
Product NDC 0591-3875
11-digit product format 005913875
Labeler code 0591
Product ID 0591-3875_985e1190-b8a0-4775-9a20-ad1924b14fb2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name memantine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA021487
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-04-01
Marketing end 2028-02-29
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
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021487-001 NAMENDA MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL RLD 2003-10-16 N021487-002 NAMENDA MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL RLD 2003-10-16
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N021487-001 NAMENDA 5MG TABLET / ORAL RLD 2003-10-16 a50c72e98297…2026-08-01 22:54:32 2026-06 N021487-002 NAMENDA 10MG TABLET / ORAL RLD 2003-10-16 a50c72e98297…
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 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base memantine hydrochloride Active Ingredients# Ingredient, Strength table Ingredient Strength MEMANTINE HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JY0WD0UA60 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996561 Internal RxNorm lookup 996571 Internal RxNorm lookup 996572 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0591-3875-44 memantine hydrochloride 10 in 1 BOX, UNIT-DOSE TABLET 10 10 0591-3875-45 memantine hydrochloride 10 in 1 BLISTER PACK TABLET 10 10 0591-3875-60 memantine hydrochloride 60 in 1 BOTTLE TABLET 60 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEMANTINE HYDROCHLORIDE ACTIVE INGREDIENT JY0WD0UA60 MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 memantine ACTIVE MOIETY W8O17SJF3T MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 FD&C blue No. 2 INACTIVE INGREDIENT L06K8R7DQK MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 polyethylene glycol 400 INACTIVE INGREDIENT B697894SGQ MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 sodium citrate INACTIVE INGREDIENT 1Q73Q2JULR MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 sorbitol INACTIVE INGREDIENT 506T60A25R MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE SOLUTION MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-3875 MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC.] 10 Current NDC, Legacy NDC, 3 package rows 20240509_72973b46-f307-4a9e-8fb1-ad2cbccfd736.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0591-3875-44 00591387544 10 BLISTER PACK in 1 BOX, UNIT-DOSE (0591-3875-44) / 10 TABLET in 1 BLISTER PACK (0591-3875-45) 10 blister pack 2015-04-01 2027-07-31 No No Current 0591-3875-45 00591387545 10 in 1 BLISTER PACK Historical 0591-3875-60 00591387560 60 TABLET in 1 BOTTLE (0591-3875-60) 60 tablet 2015-04-01 2028-02-29 No No Current