Home NDC 61442-192 Memantine Hydrochloride
Product NDC 61442-192
11-digit product format 614420192
Labeler code 61442
Product ID 61442-192_3430551c-c9c0-c8ab-e063-6394a90adfba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Carlsbad Technology, Inc.
Application ANDA212947
Marketing category ANDA
Marketing start 2025-06-22
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 2027-12-31
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 A212947-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-04-03 A212947-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-04-03
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 A212947-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2020-04-03 a50c72e98297…2026-08-01 22:54:32 2026-06 A212947-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2020-04-03 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 A212947-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A212947-002 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 · 1 matching rows.
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 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 61442-192-05 Memantine Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 2 61442-192-60 Memantine Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 61442-192-05 61442019205 500 TABLET, FILM COATED in 1 BOTTLE (61442-192-05) 2025-06-22 No No Current 61442-192-60 61442019260 60 TABLET, FILM COATED in 1 BOTTLE (61442-192-60) 2025-06-22 No No Current