Home NDC 0527-1943 Memantine Hydrochloride
Product NDC 0527-1943
11-digit product format 005271943
Labeler code 0527
Product ID 0527-1943_bd33c8de-5194-4b37-8a5f-c2b691d6aa5d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Lannett Company, Inc.
Application ANDA204033
Marketing category ANDA
Marketing start 2015-10-13
Marketing end 2024-05-31
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
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 A204033-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 2015-10-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204033-001 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 A204033-001 MEMANTINE HYDROCHLORIDE 2MG/ML SOLUTION / ORAL AA RS 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 A204033-001 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 · 2 matching rows.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MEMANTINE HYDROCHLORIDE ACTIVE INGREDIENT JY0WD0UA60 MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 MEMANTINE ACTIVE MOIETY W8O17SJF3T MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 SODIUM CITRATE, UNSPECIFIED FORM INACTIVE INGREDIENT 1Q73Q2JULR MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11 WATER INACTIVE INGREDIENT 059QF0KO0R MEMANTINE HYDROCHLORIDE SOLUTION [LANNETT COMPANY, INC.] 11
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0527-1943-13 00527194313 360 mL in 1 BOTTLE, PLASTIC (0527-1943-13) 360 ml 2015-10-13 0000-00-00 No No Current