Home NDC 0832-1113 Memantine Hydrochloride
Product NDC 0832-1113
11-digit product format 008321113
Labeler code 0832
Product ID 0832-1113_45af280b-1724-c805-e063-6294a90a76ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Upsher-Smith Laboratories, LLC
Application ANDA090043
Marketing category ANDA
Marketing start 2015-07-31
Marketing end 2028-01-31
Substance MEMANTINE HYDROCHLORIDE
Active strength 10 mg/1
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090043-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 A090043-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31
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 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 a50c72e98297…2026-08-01 22:54:32 2026-06 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 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 A090043-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A090043-002 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 Active Ingredients# Ingredient, Strength table Ingredient Strength MEMANTINE HYDROCHLORIDE 10 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 0832-1113-60 Memantine Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Memantine Hydrochloride ACTIVE INGREDIENT JY0WD0UA60 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] 1 memantine ACTIVE MOIETY W8O17SJF3T MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] 1 ferric oxide red INACTIVE INGREDIENT 1K09F3G675 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] 1 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] 1 ferrosoferric oxide INACTIVE INGREDIENT XM0M87F357 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] 1 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] 1 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] 1 talc INACTIVE INGREDIENT 7SEV7J4R1U MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0832-1113 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC] 8 Current NDC, Legacy NDC, 1 package rows 20230324_6e0ade9e-b721-4701-bcb7-de464e19e707.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 0832-1113-60 00832111360 60 TABLET, FILM COATED in 1 BOTTLE (0832-1113-60) 2015-07-31 2028-01-31 No No Current