Home NDC 0832-1112 Memantine Hydrochloride
Product NDC 0832-1112
11-digit product format 008321112
Labeler code 0832
Product ID 0832-1112_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 5 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 42 .
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.
Product history page 1 of 3 · 84 observed 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 2026-08-18 06:07:40 2026-07 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090043-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-07-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090043-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-07-31 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Memantine Hydrochloride 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 0832-1112-60 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 0832-1112 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC] 8 Current NDC, Legacy NDC, 1 package rows 20230324_6e0ade9e-b721-4701-bcb7-de464e19e707.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 0832-1112-60 00832111260 60 TABLET, FILM COATED in 1 BOTTLE (0832-1112-60) 2015-07-31 2028-01-31 No No Current