memantine hydrochloride

Generic: memantine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

memantine hydrochloride 5 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6505
Product ID 0904-6505_f98561aa-0a02-4e99-bacb-d92c81833bbe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090048
Listing Expiration 2026-12-31
Marketing Start 2015-07-20

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 09046505
Hyphenated Format 0904-6505

Supplemental Identifiers

RxCUI
996561 996571
UNII
JY0WD0UA60

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 ANDA090048 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (0904-6505-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 100 BLISTER PACK in 1 CARTON (0904-6505-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

0904-6505-06 50 BLISTER PACK in 1 CARTON (0904-6505-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0904-6505-61 100 BLISTER PACK in 1 CARTON (0904-6505-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

memantine hydrochloride (5 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": "f98561aa-0a02-4e99-bacb-d92c81833bbe", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["d0a5e0fc-04e3-417d-bef3-9b309ff71597"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-6505-06)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6505-06", "marketing_start_date": "20150720"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6505-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6505-61", "marketing_start_date": "20150720"}], "brand_name": "Memantine Hydrochloride", "product_id": "0904-6505_f98561aa-0a02-4e99-bacb-d92c81833bbe", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "0904-6505", "generic_name": "Memantine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090048", "marketing_category": "ANDA", "marketing_start_date": "20150720", "listing_expiration_date": "20261231"}