Home NDC 50090-5832 Memantine Hydrochloride
Product NDC 50090-5832
11-digit product format 500905832
Labeler code 50090
Product ID 50090-5832_fdbbca96-290b-4c82-b8ca-3f27106a5921
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA202840
Marketing category ANDA
Marketing start 2015-10-13
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 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 A202840-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 A202840-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202840-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A202840-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Memantine Hydrochloride
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996561 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 50090-5832-0 Memantine Hydrochloride 90 in 1 BOTTLE TABLET 90 5 50090-5832-1 Memantine Hydrochloride 60 in 1 BOTTLE TABLET 60 5 50090-5832-2 Memantine Hydrochloride 180 in 1 BOTTLE TABLET 180 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5832 MEMANTINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS] 5 Current NDC, Legacy NDC, 3 package rows 20231125_66db6d61-cf1d-46ca-a645-19e9a20f4617.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 · 2 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 50090-5832-0 50090583200 90 TABLET in 1 BOTTLE (50090-5832-0) 90 tablet 2021-10-27 0000-00-00 No No Current 50090-5832-1 50090583201 60 TABLET in 1 BOTTLE (50090-5832-1) 60 tablet 2022-03-01 0000-00-00 No No Current 50090-5832-2 50090583202 180 TABLET in 1 BOTTLE (50090-5832-2) 180 tablet 2022-03-01 0000-00-00 No No Current