memantine hydrochloride

Generic: memantine hydrochloride

Labeler: viona pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler viona pharmaceuticals inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

memantine hydrochloride 10 mg/1

Manufacturer
Viona Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 72578-004
Product ID 72578-004_2dee57d8-27d7-481c-b1c9-21375e258a1b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090961
Listing Expiration 2026-12-31
Marketing Start 2019-02-28

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 72578004
Hyphenated Format 72578-004

Supplemental Identifiers

RxCUI
996561 996571
UPC
0372578004149 0372578003142
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 ANDA090961 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (72578-004-01)
  • 500 TABLET in 1 BOTTLE (72578-004-05)
  • 1000 TABLET in 1 BOTTLE (72578-004-10)
  • 60 TABLET in 1 BOTTLE (72578-004-14)
  • 10 BLISTER PACK in 1 CARTON (72578-004-77) / 10 TABLET in 1 BLISTER PACK (72578-004-30)
source: ndc

Packages (5)

72578-004-01 100 TABLET in 1 BOTTLE (72578-004-01) 72578-004-05 500 TABLET in 1 BOTTLE (72578-004-05) 72578-004-10 1000 TABLET in 1 BOTTLE (72578-004-10) 72578-004-14 60 TABLET in 1 BOTTLE (72578-004-14) 72578-004-77 10 BLISTER PACK in 1 CARTON (72578-004-77) / 10 TABLET in 1 BLISTER PACK (72578-004-30)

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": "2dee57d8-27d7-481c-b1c9-21375e258a1b", "openfda": {"upc": ["0372578004149", "0372578003142"], "unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["dcbdb62a-a4e2-4058-b73c-46005f2a5d51"], "manufacturer_name": ["Viona Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (72578-004-01)", "package_ndc": "72578-004-01", "marketing_start_date": "20190228"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72578-004-05)", "package_ndc": "72578-004-05", "marketing_start_date": "20190228"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (72578-004-10)", "package_ndc": "72578-004-10", "marketing_start_date": "20190228"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72578-004-14)", "package_ndc": "72578-004-14", "marketing_start_date": "20190228"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (72578-004-77)  / 10 TABLET in 1 BLISTER PACK (72578-004-30)", "package_ndc": "72578-004-77", "marketing_start_date": "20190228"}], "brand_name": "Memantine Hydrochloride", "product_id": "72578-004_2dee57d8-27d7-481c-b1c9-21375e258a1b", "dosage_form": "TABLET", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "72578-004", "generic_name": "Memantine Hydrochloride", "labeler_name": "Viona Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090961", "marketing_category": "ANDA", "marketing_start_date": "20190228", "listing_expiration_date": "20261231"}