Home NDC 42934-300-31 Memantine Hydrochloride
Product NDC 42934-300
Requested package NDC 42934-300-31
11-digit product format 429340300
Labeler code 42934
Product ID 42934-300_aecb951d-a5af-1a10-e053-2a95a90ab426
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine Hydrochloride Oral
Dosage form SOLUTION
Route ORAL
Labeler Medley Pharmaceuticals Limited
Application ANDA210319
Marketing category ANDA
Marketing start 2017-04-22
Marketing end 0000-00-00
Substance MEMANTINE HYDROCHLORIDE
Active strength 2 mg/mL
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210319-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210319-001 AA
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.
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 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 42934-300-31 42934030031 360 mL in 1 BOTTLE (42934-300-31) 360 ml 2017-04-22 0000-00-00 No No Current