Home NDC 33342-312 Memantine and Donepezil
Product NDC 33342-312
11-digit product format 333420312
Labeler code 33342
Product ID 33342-312_3d9a23dc-8cbe-47c3-a048-70d86cb9dc14
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Memantine and Donepezil
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA208672
Marketing category ANDA
Marketing start 2025-07-15
Substance DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Active strength 10; 14 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 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 A208672-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE 10MG;14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-15 A208672-002 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE 10MG;28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-15
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 2026-08-18 06:07:40 2026-07 A208672-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208672-002 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208672-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208672-002 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208672-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208672-002 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208672-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208672-002 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-15 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208672-001 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208672-002 MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE 10MG;28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-07-15 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Memantine and Donepezil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MEMANTINE HYDROCHLORIDE 14 mg/1 DONEPEZIL HYDROCHLORIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3O2T2PJ89D Internal UNII lookup 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 1599803 Internal RxNorm lookup 1599805 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 33342-312-07 Memantine and Donepezil 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 1 33342-312-10 Memantine and Donepezil 90 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 90 1 33342-312-12 Memantine and Donepezil 10 in 1 CARTON CAPSULE, EXTENDED RELEASE 10 1 33342-312-12 Memantine and Donepezil 10 in 1 BLISTER PACK CAPSULE, EXTENDED RELEASE 10 1
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 Sample Exclude flag Status 33342-312-07 33342031207 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-07) 2025-07-15 No No Current 33342-312-10 33342031210 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-312-10) 2025-07-15 No No Current 33342-312-12 33342031212 10 BLISTER PACK in 1 CARTON (33342-312-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK 10 blister pack 2025-07-15 No No Current