memantine hydrochloride

Generic: memantine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

memantine hydrochloride 10 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-169
Product ID 65162-169_e3662d8d-b6da-40c6-84d4-1b5d467b1eb8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090041
Listing Expiration 2026-12-31
Marketing Start 2022-03-24

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 65162169
Hyphenated Format 65162-169

Supplemental Identifiers

RxCUI
996561 996571
UPC
0365162169065
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 (source: ndc)
Application Number ANDA090041 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (65162-169-06)
source: ndc

Packages (1)

65162-169-06 60 TABLET, FILM COATED in 1 BOTTLE (65162-169-06)

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": "e3662d8d-b6da-40c6-84d4-1b5d467b1eb8", "openfda": {"upc": ["0365162169065"], "unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["f73e0df0-4af4-42f1-bde6-3cccb47ca378"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (65162-169-06)", "package_ndc": "65162-169-06", "marketing_start_date": "20220324"}], "brand_name": "memantine hydrochloride", "product_id": "65162-169_e3662d8d-b6da-40c6-84d4-1b5d467b1eb8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "65162-169", "generic_name": "memantine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "memantine hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090041", "marketing_category": "ANDA", "marketing_start_date": "20220324", "listing_expiration_date": "20261231"}