Home NDC 68999-943 Memantine Hydrochloride
Product NDC 68999-943
11-digit product format 689990943
Labeler code 68999
Product ID 68999-943_4a2cbed1-d548-b830-e063-6394a90a0ee6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Chartwell Governmental & Specialty RX, LLC.
Application ANDA204033
Marketing category ANDA
Marketing start 2015-10-13
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 2027-12-31
Current FDA listing Yes 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 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 · 43 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 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Memantine Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEMANTINE HYDROCHLORIDE 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JY0WD0UA60 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996740 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68999-943-05 Memantine Hydrochloride 5 mL in 1 CUP SOLUTION 5 1 68999-943-24 Memantine Hydrochloride 10 in 1 TRAY SOLUTION 10 1 68999-943-24 Memantine Hydrochloride 2 in 1 BOX SOLUTION 2 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68999-943-05 68999094305 5 mL in 1 CUP 5 ml Historical 68999-943-24 68999094324 2 TRAY in 1 BOX (68999-943-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-943-05) 2 tray 2026-02-02 No No Current