Home NDC 52605-072-10 Memantine hydrochloride
Product NDC 52605-072
Requested package NDC 52605-072-10
11-digit product format 526050072
Labeler code 52605
Product ID 52605-072_4fe4f372-10c2-42ca-bc69-d78a489672b2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler POLYGEN PHARMACEUTICALS INC.
Application ANDA210587
Marketing category ANDA
Marketing start 2021-07-01
Marketing end 0000-00-00
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 2023-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A210587-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 A210587-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11
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 · 74 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 2026-09-14 22:38:34 2026-08 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210587-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-12-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210587-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-12-11 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52605-072-10 Memantine hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4 52605-072-13 Memantine hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 4 52605-072-16 Memantine hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52605-072 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [POLYGEN PHARMACEUTICALS INC.] 4 Legacy NDC, 3 package rows 20221202_c343b0c5-3bfc-4b94-9483-a56924f6dcdb.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52605-072-10 52605007210 1000 TABLET, FILM COATED in 1 BOTTLE (52605-072-10) 2021-07-01 0000-00-00 No No Current