Home NDC 68180-230 Memantine hydrochloride
Product NDC 68180-230
11-digit product format 681800230
Labeler code 68180
Product ID 68180-230_392d48fd-7c93-40f3-9ab0-d0f304b7e439
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA090051
Marketing category ANDA
Marketing start 2015-07-13
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
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A090051-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 A090051-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10
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 · 86 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 2026-09-14 22:38:34 2026-08 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090051-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2015-04-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090051-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2015-04-10 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Memantine hydrochloride
Listing expiration 2026-12-31 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 68180-230-07 Memantine hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 13 68180-230-11 Memantine hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 13
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 [LUPIN PHARMACEUTICALS, INC.] 2 MEMANTINE ACTIVE MOIETY W8O17SJF3T MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68180-230 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [LUPIN PHARMACEUTICALS, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20250528_1b4a0162-9cb4-4ba6-8c02-95c2955734ae.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 Units Marketing start Marketing end Sample Exclude flag Status 68180-230-07 68180023007 60 TABLET, FILM COATED in 1 BOTTLE (68180-230-07) 2015-07-13 0000-00-00 No No Current 68180-230-11 68180023011 10 in 1 BLISTER PACK Historical 68180-230-13 68180023013 10 BLISTER PACK in 1 CARTON (68180-230-13) > 10 TABLET, FILM COATED in 1 BLISTER PACK (68180-230-11) 10 blister pack 2015-07-13 0000-00-00 No No Current