memantine hydrochloride and donepezil hydrochloride

Generic: memantine hydrochloride and donepezil hydrochloride

Labeler: vitruvias therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride and donepezil hydrochloride
Generic Name memantine hydrochloride and donepezil hydrochloride
Labeler vitruvias therapeutics, inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

donepezil hydrochloride 10 mg/1, memantine hydrochloride 14 mg/1

Manufacturer
Vitruvias Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 69680-183
Product ID 69680-183_ffe5cf41-299a-49e5-a9b8-c9048c4861fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216901
Listing Expiration 2026-12-31
Marketing Start 2025-07-16

Pharmacologic Class

Classes
cholinesterase inhibitor [epc] cholinesterase inhibitors [moa] n-methyl-d-aspartate receptor antagonist [epc] nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69680183
Hyphenated Format 69680-183

Supplemental Identifiers

RxCUI
1599803 1599805
UPC
0369680183305 0369680185309
UNII
JY0WD0UA60 3O2T2PJ89D

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name memantine hydrochloride and donepezil hydrochloride (source: ndc)
Generic Name memantine hydrochloride and donepezil hydrochloride (source: ndc)
Application Number ANDA216901 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 14 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-183-30)
source: ndc

Packages (1)

69680-183-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-183-30)

Ingredients (2)

donepezil hydrochloride (10 mg/1) memantine hydrochloride (14 mg/1)

Linked Drug Pages (1)

memantine hydrochloride and donepezil hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ffe5cf41-299a-49e5-a9b8-c9048c4861fa", "openfda": {"upc": ["0369680183305", "0369680185309"], "unii": ["JY0WD0UA60", "3O2T2PJ89D"], "rxcui": ["1599803", "1599805"], "spl_set_id": ["c888a2b2-92c6-46ae-99ea-21de616208b6"], "manufacturer_name": ["Vitruvias Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-183-30)", "package_ndc": "69680-183-30", "marketing_start_date": "20250716"}], "brand_name": "memantine hydrochloride and donepezil hydrochloride", "product_id": "69680-183_ffe5cf41-299a-49e5-a9b8-c9048c4861fa", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Cholinesterase Inhibitor [EPC]", "Cholinesterase Inhibitors [MoA]", "N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "69680-183", "generic_name": "memantine hydrochloride and donepezil hydrochloride", "labeler_name": "Vitruvias Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "memantine hydrochloride and donepezil hydrochloride", "active_ingredients": [{"name": "DONEPEZIL HYDROCHLORIDE", "strength": "10 mg/1"}, {"name": "MEMANTINE HYDROCHLORIDE", "strength": "14 mg/1"}], "application_number": "ANDA216901", "marketing_category": "ANDA", "marketing_start_date": "20250716", "listing_expiration_date": "20261231"}