memantine hydrochloride

Generic: memantine hydrochloride

Labeler: carlsbad technology, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler carlsbad technology, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

memantine hydrochloride 10 mg/1

Manufacturer
Carlsbad Technology, Inc.

Identifiers & Regulatory

Product NDC 61442-193
Product ID 61442-193_3430551c-c9c0-c8ab-e063-6394a90adfba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212947
Listing Expiration 2027-12-31
Marketing Start 2025-06-22

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 61442193
Hyphenated Format 61442-193

Supplemental Identifiers

RxCUI
996561 996571
UPC
0361442192051 0361442193058
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 ANDA212947 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (61442-193-05)
  • 60 TABLET, FILM COATED in 1 BOTTLE (61442-193-60)
source: ndc

Packages (2)

61442-193-05 500 TABLET, FILM COATED in 1 BOTTLE (61442-193-05) 61442-193-60 60 TABLET, FILM COATED in 1 BOTTLE (61442-193-60)

Ingredients (1)

memantine hydrochloride (10 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": "3430551c-c9c0-c8ab-e063-6394a90adfba", "openfda": {"upc": ["0361442192051", "0361442193058"], "unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["30b4d5c4-0a31-c385-e063-6394a90adbce"], "manufacturer_name": ["Carlsbad Technology, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (61442-193-05)", "package_ndc": "61442-193-05", "marketing_start_date": "20250622"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (61442-193-60)", "package_ndc": "61442-193-60", "marketing_start_date": "20250622"}], "brand_name": "Memantine Hydrochloride", "product_id": "61442-193_3430551c-c9c0-c8ab-e063-6394a90adfba", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "61442-193", "generic_name": "Memantine Hydrochloride", "labeler_name": "Carlsbad Technology, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA212947", "marketing_category": "ANDA", "marketing_start_date": "20250622", "listing_expiration_date": "20271231"}