Home NDC 0527-1943 Memantine Hydrochloride
Product NDC 0527-1943
11-digit product format 005271943
Labeler code 0527
Product ID 0527-1943_bd33c8de-5194-4b37-8a5f-c2b691d6aa5d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA204033
Marketing category ANDA
Marketing start 2015-10-13
Marketing end 2024-05-31
Substance MEMANTINE HYDROCHLORIDE
Active strength 2 mg/mL
Pharmacologic classes N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0527-1943-13 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0527-1943-13 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0527-1943-13 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0527-1943-13 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0527-1943-13 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0527-1943-13 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0527-1943-13 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0527-1943-13 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0527-1943-13 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0527-1943-13 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0527-1943-13 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0527-1943-13 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A204033-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204033-001 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.
Product history page 1 of 2 · 41 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 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2015-10-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2015-10-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2015-10-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEMANTINE HYDROCHLORIDE ACTIVE INGREDIENT JY0WD0UA60 MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 MEMANTINE ACTIVE MOIETY W8O17SJF3T MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 SODIUM CITRATE, UNSPECIFIED FORM INACTIVE INGREDIENT 1Q73Q2JULR MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 WATER INACTIVE INGREDIENT 059QF0KO0R MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11
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 Units Marketing start Marketing end Sample Exclude flag Status 0527-1943-13 00527194313 360 mL in 1 BOTTLE, PLASTIC (0527-1943-13) 360 ml 2015-10-13 0000-00-00 No No Current