Home NDC 50090-7348 memantine hydrochloride
Product NDC 50090-7348
11-digit product format 500907348
Labeler code 50090
Product ID 50090-7348_268c8634-c170-4123-a681-5c0ec4ee45c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name memantine hydrochloride
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA204389
Marketing category ANDA
Marketing start 2022-09-26
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 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 A204389-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 A204389-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26
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 2 · 54 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 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204389-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2022-09-26 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204389-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2022-09-26 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 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 5 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 996571 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 50090-7348-0 memantine hydrochloride 60 in 1 BOTTLE TABLET 60 1 50090-7348-1 memantine hydrochloride 90 in 1 BOTTLE TABLET 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-7348 MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE) TABLET [A-S MEDICATION SOLUTIONS] 1 Current NDC, 2 package rows 20241023_4d48c958-b606-4427-8502-53450718eefb.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 Sample Exclude flag Status 50090-7348-0 50090734800 60 TABLET in 1 BOTTLE (50090-7348-0) 60 tablet 2024-10-16 No No Current 50090-7348-1 50090734801 90 TABLET in 1 BOTTLE (50090-7348-1) 90 tablet 2024-10-16 No No Current