Home NDC 13925-540 Memantine Hydrochloride
Product NDC 13925-540
11-digit product format 139250540
Labeler code 13925
Product ID 13925-540_cd1fd2cb-7154-4ef6-ac18-e0646a7be6e9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine Hydrochloride Oral
Dosage form SOLUTION
Route ORAL
Labeler Seton Pharmaceuticals
Application ANDA210319
Marketing category ANDA
Marketing start 2020-08-31
Marketing end 2027-03-31
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
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 A210319-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210319-001 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 A210319-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA 2020-08-31 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 A210319-001 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 Hydrochloride 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 13925-540-12 Memantine Hydrochloride 360 mL in 1 BOTTLE SOLUTION 360 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13925-540 MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE ORAL) SOLUTION [SETON PHARMACEUTICALS] 4 Current NDC, Legacy NDC, 1 package rows 20240131_421f6478-09df-49d3-a7c4-52814b4aa90e.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 13925-540-12 13925054012 360 mL in 1 BOTTLE (13925-540-12) 360 ml 2021-05-19 2027-03-31 No No Current