Home NDC 59651-404 MEMANTINE HYDROCHLORIDE
Product NDC 59651-404
11-digit product format 596510404
Labeler code 59651
Product ID 59651-404_7a208302-90f3-45d0-94fc-9fb38591c543
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MEMANTINE HYDROCHLORIDE
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA214651
Marketing category ANDA
Marketing start 2021-08-09
Substance MEMANTINE HYDROCHLORIDE
Active strength 7 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214651-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-08-09 A214651-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-08-09 A214651-003 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-08-09 A214651-004 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-08-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 A214651-001 MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-08-09 a50c72e98297…2026-08-01 22:54:32 2026-06 A214651-002 MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-08-09 a50c72e98297…2026-08-01 22:54:32 2026-06 A214651-003 MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-08-09 a50c72e98297…2026-08-01 22:54:32 2026-06 A214651-004 MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-08-09 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 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 7 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 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996594 Internal RxNorm lookup 996603 Internal RxNorm lookup 996609 Internal RxNorm lookup 996615 Internal RxNorm lookup 996624 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 59651-404-30 MEMANTINE HYDROCHLORIDE 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 2 59651-404-90 MEMANTINE HYDROCHLORIDE 90 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 90 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-404 MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE MEMANTINE HYDROCHLORIDE KIT [AUROBINDO PHARMA LIMITED] 2 Current NDC, Legacy NDC, 2 package rows 20221106_2b2dcd54-47e0-494b-85d2-c28c3adbe737.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 59651-404-30 59651040430 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-404-30) 2021-08-09 0000-00-00 No No Current 59651-404-90 59651040490 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59651-404-90) 2021-08-09 0000-00-00 No No Current