Home NDC 60505-6162 MEMANTINE
Product NDC 60505-6162
11-digit product format 605056162
Labeler code 60505
Product ID 60505-6162_909dca28-d83f-dbc8-25a0-6f6a40ea2ccc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name memantine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Apotex Corp.
Application ANDA209955
Marketing category ANDA
Marketing start 2018-04-30
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 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209955-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2018-02-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209955-001 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.
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 A209955-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2018-02-09 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 A209955-001 AA 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
Listing expiration 2026-12-31 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 60505-6162-5 MEMANTINE 1 in 1 CARTON SOLUTION 1 6 60505-6162-5 MEMANTINE 360 mL in 1 BOTTLE SOLUTION 360 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6162 MEMANTINE (MEMANTINE HYDROCHLORIDE) SOLUTION [APOTEX CORP.] 6 Current NDC, Legacy NDC, 2 package rows 20250411_4076d3ef-d0a9-96c5-1a15-812c1e42929c.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60505-6162-5 60505616205 1 BOTTLE in 1 CARTON (60505-6162-5) / 360 mL in 1 BOTTLE 1 bottle 2018-04-30 0000-00-00 No No Current