Home NDC 62332-075 Memantine Hydrochloride
Product NDC 62332-075
11-digit product format 623320075
Labeler code 62332
Product ID 62332-075_9792a0a6-a48e-4998-9f5a-c9eaa144edea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name memantine hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Alembic Pharmaceuticals Inc.
Application ANDA200891
Marketing category ANDA
Marketing start 2015-10-13
Substance MEMANTINE HYDROCHLORIDE
Active strength 5 mg/1
Pharmacologic classes N-methyl-D-aspartate Receptor Antagonist [EPC], NMDA Receptor Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A200891-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 A200891-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13
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 3 · 84 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 2026-08-18 06:07:40 2026-07 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Memantine Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEMANTINE HYDROCHLORIDE 5 mg/1
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996561 Internal RxNorm lookup 996571 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 62332-075-10 Memantine Hydrochloride 100 in 1 CARTON TABLET, COATED 100 13 62332-075-20 Memantine Hydrochloride 20 in 1 BOTTLE TABLET, COATED 20 13 62332-075-30 Memantine Hydrochloride 30 in 1 BOTTLE TABLET, COATED 30 13 62332-075-31 Memantine Hydrochloride 100 in 1 BOTTLE TABLET, COATED 100 13 62332-075-42 Memantine Hydrochloride 3000 in 1 BOTTLE TABLET, COATED 3000 13 62332-075-60 Memantine Hydrochloride 60 in 1 BOTTLE TABLET, COATED 60 13 62332-075-91 Memantine Hydrochloride 1000 in 1 BOTTLE TABLET, COATED 1000 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEMANTINE HYDROCHLORIDE ACTIVE INGREDIENT JY0WD0UA60 MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 MEMANTINE ACTIVE MOIETY W8O17SJF3T MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-075 MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS INC.] 13 Current NDC, Legacy NDC, 7 package rows 20211012_af2b73da-1be4-4b7f-929b-acb3b9a10f78.zip
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 Marketing start Marketing end Sample Exclude flag Status 62332-075-10 62332007510 100 TABLET, COATED in 1 CARTON (62332-075-10) 2015-10-13 0000-00-00 No No Current 62332-075-20 62332007520 20 TABLET, COATED in 1 BOTTLE (62332-075-20) 2015-10-13 0000-00-00 No No Current 62332-075-30 62332007530 30 TABLET, COATED in 1 BOTTLE (62332-075-30) 2015-10-13 0000-00-00 No No Current 62332-075-31 62332007531 100 TABLET, COATED in 1 BOTTLE (62332-075-31) 2015-10-13 0000-00-00 No No Current 62332-075-42 62332007542 3000 TABLET, COATED in 1 BOTTLE (62332-075-42) 2015-10-13 0000-00-00 No No Current 62332-075-60 62332007560 60 TABLET, COATED in 1 BOTTLE (62332-075-60) 2015-10-13 0000-00-00 No No Current 62332-075-91 62332007591 1000 TABLET, COATED in 1 BOTTLE (62332-075-91) 2015-10-13 0000-00-00 No No Current