Home NDC 64380-745-30 memantine hydrochloride
Product NDC 64380-745
Requested package NDC 64380-745-30
11-digit product format 643800745
Labeler code 64380
Product ID 64380-745_db43c81e-0277-47ca-ab97-0cba3240bc37
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name memantine hydrochloride
Dosage form TABLET
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA202350
Marketing category ANDA
Marketing start 2017-05-23
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 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64380-745 64380-745-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64380-745 64380-745-30 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A202350-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2017-05-23 A202350-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2017-05-23
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 · 86 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 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2017-05-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2017-05-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL 2017-05-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL 2017-05-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202350-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2017-05-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A202350-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2017-05-23 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64380-745-30 64380074530 10 BLISTER PACK in 1 CARTON (64380-745-30) > 10 TABLET in 1 BLISTER PACK 10 blister pack 2017-05-23 0000-00-00 No No Current