Home NDC 62559-207 MEMANTINE AND DONEPEZIL HYDROCHLORIDES
Product NDC 62559-207
11-digit product format 625590207
Labeler code 62559
Product ID 62559-207_cd8d0e95-24ac-43e1-9d43-bb081b4f341e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MEMANTINE AND DONEPEZIL HYDROCHLORIDES
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA208237
Marketing category ANDA
Marketing start 2025-01-01
Substance DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Active strength 10; 21 mg/1; mg/1
Pharmacologic classes Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA], 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 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 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208237-001 AB
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 2026-02-19 14:30 UTC 2026-02 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208237-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2023-12-15 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base MEMANTINE AND DONEPEZIL HYDROCHLORIDES
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEMANTINE HYDROCHLORIDE 10 mg/1 DONEPEZIL HYDROCHLORIDE 21 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JY0WD0UA60 Internal UNII lookup 3O2T2PJ89D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1805420 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 62559-207-30 MEMANTINE AND DONEPEZIL HYDROCHLORIDES 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-207 MEMANTINE AND DONEPEZIL HYDROCHLORIDES CAPSULE, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20250101_c42a995d-cd0f-466c-8f47-43c7f32d9675.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 Sample Exclude flag Status 62559-207-30 62559020730 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-207-30) 2025-01-01 No No Current