Home NDC 46708-452 Memantine Hydrochloride
Product NDC 46708-452
11-digit product format 467080452
Labeler code 46708
Product ID 46708-452_3d66d5be-d570-4041-82bf-6b6f4eef9ed8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name memantine hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA200891
Marketing category ANDA
Marketing start 2015-10-13
Substance MEMANTINE HYDROCHLORIDE
Active strength 10 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 1 .
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.
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 2026-08-01 22:54:32 2026-06 A200891-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-10-13 a50c72e98297…2026-08-01 22:54:32 2026-06 A200891-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-10-13 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A200891-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A200891-002 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 10 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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 46708-452-10 2023-02-01 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-20 2023-02-01 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-30 2023-02-01 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-31 2023-02-01 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-42 2023-02-01 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-60 2023-02-01 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-71 2023-02-01 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-10 2023-01-30 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-20 2023-01-30 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-30 2023-01-30 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-31 2023-01-30 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-42 2023-01-30 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-60 2023-01-30 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003 46708-452-71 2023-01-30 C162847 48780-1 f386c649-9ba0-0266-e053-dadaa90a7c1a These Highlights do not include all the information needed to use memantine hydrochloride safely and effectively. See full prescribing information for Memantine Hydrochloride Tablets. Memantine hydrochloride tablets USP, for oral use Initial U.S. Approval: 2003
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 46708-452-10 Memantine Hydrochloride 100 in 1 CARTON TABLET, COATED 100 3 46708-452-20 Memantine Hydrochloride 20 in 1 BOTTLE TABLET, COATED 20 3 46708-452-30 Memantine Hydrochloride 30 in 1 BOTTLE TABLET, COATED 30 3 46708-452-31 Memantine Hydrochloride 100 in 1 BOTTLE TABLET, COATED 100 3 46708-452-42 Memantine Hydrochloride 3000 in 1 BOTTLE TABLET, COATED 3000 3 46708-452-60 Memantine Hydrochloride 60 in 1 BOTTLE TABLET, COATED 60 3 46708-452-71 Memantine Hydrochloride 500 in 1 BOTTLE TABLET, COATED 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-452 MEMANTINE HYDROCHLORIDE TABLET, COATED [ALEMBIC PHARMACEUTICALS LIMITED] 3 Current NDC, Legacy NDC, 7 package rows 20230202_b86c0f6e-480b-40e7-aa4d-21bd0659101d.zip
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 46708-452-10 46708045210 100 TABLET, COATED in 1 CARTON (46708-452-10) 2015-10-13 0000-00-00 No No Current 46708-452-20 46708045220 20 TABLET, COATED in 1 BOTTLE (46708-452-20) 2015-10-13 0000-00-00 No No Current 46708-452-30 46708045230 30 TABLET, COATED in 1 BOTTLE (46708-452-30) 2015-10-13 0000-00-00 No No Current 46708-452-31 46708045231 100 TABLET, COATED in 1 BOTTLE (46708-452-31) 2015-10-13 0000-00-00 No No Current 46708-452-42 46708045242 3000 TABLET, COATED in 1 BOTTLE (46708-452-42) 2015-10-13 0000-00-00 No No Current 46708-452-60 46708045260 60 TABLET, COATED in 1 BOTTLE (46708-452-60) 2015-10-13 0000-00-00 No No Current 46708-452-71 46708045271 500 TABLET, COATED in 1 BOTTLE (46708-452-71) 2015-10-13 0000-00-00 No No Current