Home NDC 71610-011 memantine hydrochloride
Product NDC 71610-011
11-digit product format 716100011
Labeler code 71610
Product ID 71610-011_f384e3d8-d9fd-481c-b924-4bf98dfb5bdf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name memantine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application NDA021487
Marketing category NDA
Marketing start 2015-04-01
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 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
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 71610-011-18 memantine hydrochloride 3000 in 1 BOTTLE TABLET 3000 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-011 MEMANTINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20171201_c8f5c20b-4573-44c5-89fc-4da11b2e1fe1.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 71610-011-18 71610001118 3000 TABLET in 1 BOTTLE (71610-011-18) 3000 tablet 2017-11-15 0000-00-00 No No Current