Home NDC 43353-165-53 Memantine Hydrochloride
Product NDC 43353-165
Requested package NDC 43353-165-53
11-digit product format 433530165
Labeler code 43353
Product ID 43353-165_bd5eaa03-d2d2-4af4-855f-a3fa51a58b72
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name memantine hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA200891
Marketing category ANDA
Marketing start 2015-10-13
Marketing end 0000-00-00
Substance MEMANTINE HYDROCHLORIDE
Active strength 10 mg/1
Pharmacologic classes NMDA Receptor Antagonists [MoA],N-methyl-D-aspartate Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record 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 A200891-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 A200891-002 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 · 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 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43353-165 MEMANTINE HYDROCHLORIDE TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 2 Legacy NDC 20171003_7c093eec-e73f-42aa-acef-101e3d6d039e.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43353-165-53 43353016553 60 TABLET, COATED in 1 BOTTLE (43353-165-53) 2016-03-29 0000-00-00 No No Current