Home NDC 62135-896 memantine
Product NDC 62135-896
11-digit product format 621350896
Labeler code 62135
Product ID 62135-896_f3ba0986-42cf-a016-e053-2995a90a7c9f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name memantine
Dosage form TABLET
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA090244
Marketing category ANDA
Marketing start 2018-07-11
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090244-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 A090244-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090244-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2018-07-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A090244-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2018-07-11 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base memantine
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996561 Internal RxNorm lookup 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 62135-896-60 memantine 60 in 1 BOTTLE TABLET 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-896 MEMANTINE TABLET [CHARTWELL RX, LLC] 1 Current NDC, 1 package rows 20230203_6906b0b4-1944-40f0-844a-e0db72ba4675.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 · 1 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 62135-896-60 62135089660 60 TABLET in 1 BOTTLE (62135-896-60) 60 tablet 2023-02-01 No No Current