Home NDC 47335-322 Memantine Hydrochloride
Product NDC 47335-322
11-digit product format 473350322
Labeler code 47335
Product ID 47335-322_81ca8cbf-7854-43a2-bd0b-1dbaf4709a42
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA090058
Marketing category ANDA
Marketing start 2015-07-11
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 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 A090058-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 A090058-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05
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 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090058-001 MEMANTINE HYDROCHLORIDE 5MG TABLET / ORAL AB 2010-05-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A090058-002 MEMANTINE HYDROCHLORIDE 10MG TABLET / ORAL AB 2010-05-05 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
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 47335-322-08 Memantine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 13 47335-322-13 Memantine Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 13 47335-322-18 Memantine Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 13 47335-322-83 Memantine Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 13 47335-322-86 Memantine Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 13 47335-322-88 Memantine Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 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 [SUN PHARMA GLOBAL FZE] 4 MEMANTINE ACTIVE MOIETY W8O17SJF3T MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMA GLOBAL FZE] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47335-322 MEMANTINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 13 Current NDC, Legacy NDC, 6 package rows 20231006_d1963395-3cf7-4433-bf2c-06295bb1c5b0.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 · 2 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 47335-322-08 47335032208 100 TABLET, FILM COATED in 1 BOTTLE (47335-322-08) 2015-07-11 0000-00-00 No No Current 47335-322-13 47335032213 500 TABLET, FILM COATED in 1 BOTTLE (47335-322-13) 2015-07-11 0000-00-00 No No Current 47335-322-18 47335032218 1000 TABLET, FILM COATED in 1 BOTTLE (47335-322-18) 2015-07-11 0000-00-00 No No Current 47335-322-83 47335032283 30 TABLET, FILM COATED in 1 BOTTLE (47335-322-83) 2015-07-11 0000-00-00 No No Current 47335-322-86 47335032286 60 TABLET, FILM COATED in 1 BOTTLE (47335-322-86) 2015-07-11 0000-00-00 No No Current 47335-322-88 47335032288 100 TABLET, FILM COATED in 1 BOTTLE (47335-322-88) 2015-07-11 0000-00-00 No No Current