memantine

Generic: memantine

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine
Generic Name memantine
Labeler northstar rxllc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

memantine hydrochloride 10 mg/1

Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-119
Product ID 72603-119_dd10c9a1-a7af-b51f-4317-ee2290f19a85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090048
Listing Expiration 2026-12-31
Marketing Start 2022-09-13

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 72603119
Hyphenated Format 72603-119

Supplemental Identifiers

RxCUI
996561 996571
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 (source: ndc)
Generic Name memantine (source: ndc)
Application Number ANDA090048 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (72603-119-01)
  • 500 TABLET in 1 BOTTLE (72603-119-02)
source: ndc

Packages (2)

72603-119-01 60 TABLET in 1 BOTTLE (72603-119-01) 72603-119-02 500 TABLET in 1 BOTTLE (72603-119-02)

Ingredients (1)

memantine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Memantine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dd10c9a1-a7af-b51f-4317-ee2290f19a85", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["7a40ed9d-8853-b616-ff47-0c7b0fd28959"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (72603-119-01)", "package_ndc": "72603-119-01", "marketing_start_date": "20220913"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72603-119-02)", "package_ndc": "72603-119-02", "marketing_start_date": "20220913"}], "brand_name": "Memantine", "product_id": "72603-119_dd10c9a1-a7af-b51f-4317-ee2290f19a85", "dosage_form": "TABLET", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "72603-119", "generic_name": "Memantine", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090048", "marketing_category": "ANDA", "marketing_start_date": "20220913", "listing_expiration_date": "20261231"}