memantine hydrochloride

Generic: memantine hydrochloride

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

Drug Facts

Product Profile

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

memantine hydrochloride 21 mg/1

Manufacturer
Vitruvias Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 69680-163
Product ID 69680-163_64b8e27d-8127-4df2-a089-dbcd873c4e5e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213985
Listing Expiration 2026-12-31
Marketing Start 2024-02-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69680163
Hyphenated Format 69680-163

Supplemental Identifiers

RxCUI
996594 996603 996609 996615
UPC
0369680163307 0369680162300 0369680164304 0369680161303
UNII
JY0WD0UA60

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 (source: ndc)
Generic Name memantine hydrochloride (source: ndc)
Application Number ANDA213985 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 21 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-163-30)
source: ndc

Packages (1)

69680-163-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-163-30)

Ingredients (1)

memantine hydrochloride (21 mg/1)

Linked Drug Pages (1)

Memantine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "64b8e27d-8127-4df2-a089-dbcd873c4e5e", "openfda": {"upc": ["0369680163307", "0369680162300", "0369680164304", "0369680161303"], "unii": ["JY0WD0UA60"], "rxcui": ["996594", "996603", "996609", "996615"], "spl_set_id": ["0c7fd6ab-2ce5-4110-b6e6-9103c8da0765"], "manufacturer_name": ["Vitruvias Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69680-163-30)", "package_ndc": "69680-163-30", "marketing_start_date": "20240219"}], "brand_name": "Memantine Hydrochloride", "product_id": "69680-163_64b8e27d-8127-4df2-a089-dbcd873c4e5e", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "69680-163", "generic_name": "memantine hydrochloride", "labeler_name": "Vitruvias Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "21 mg/1"}], "application_number": "ANDA213985", "marketing_category": "ANDA", "marketing_start_date": "20240219", "listing_expiration_date": "20261231"}