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.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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
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