Home NDC 0591-3900 memantine hydrochloride
Product NDC 0591-3900
11-digit product format 005913900
Labeler code 0591
Product ID 0591-3900_985e1190-b8a0-4775-9a20-ad1924b14fb2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name memantine hydrochloride
Dosage form KIT
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA021487
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-04-01
Marketing end 2028-08-31
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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.
Product history page 1 of 3 · 84 observed 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 2026-08-18 06:07:40 2026-07 N021487-001 NAMENDA 5MG TABLET / ORAL RLD 2003-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021487-002 NAMENDA 10MG TABLET / ORAL RLD 2003-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021487-001 NAMENDA 5MG TABLET / ORAL AB RLD 2003-10-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021487-002 NAMENDA 10MG TABLET / ORAL AB RLD, RS 2003-10-16 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Additional Listing Data#
Finished product Yes
Brand name base memantine hydrochloride 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 0591-3900-87 memantine hydrochloride 1 in 1 BLISTER PACK KIT 1 10 0591-3900-87 memantine hydrochloride 1 in 1 CARTON KIT 1 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 0591-3900 MEMANTINE HYDROCHLORIDE TABLET MEMANTINE HYDROCHLORIDE KIT [ACTAVIS PHARMA, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20240509_72973b46-f307-4a9e-8fb1-ad2cbccfd736.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
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 0591-3900-87 00591390087 1 BLISTER PACK in 1 CARTON (0591-3900-87) / 1 KIT in 1 BLISTER PACK 1 blister pack 2015-04-01 2028-08-31 No No Current