memantine hydrochloride

Generic: memantine hydrochloride

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

memantine hydrochloride 5 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-587
Product ID 50268-587_47e7cea9-cd6c-40d4-e063-6294a90a9e8a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200022
Listing Expiration 2027-12-31
Marketing Start 2024-02-20

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 50268587
Hyphenated Format 50268-587

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 ANDA200022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 BOX (50268-587-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-587-11)
source: ndc

Packages (1)

50268-587-13 30 BLISTER PACK in 1 BOX (50268-587-13) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-587-11)

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": "47e7cea9-cd6c-40d4-e063-6294a90a9e8a", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["11d27c75-fdc0-f9da-e063-6394a90ac6b0"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 BOX (50268-587-13)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-587-11)", "package_ndc": "50268-587-13", "marketing_start_date": "20240220"}], "brand_name": "Memantine Hydrochloride", "product_id": "50268-587_47e7cea9-cd6c-40d4-e063-6294a90a9e8a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "50268-587", "generic_name": "memantine hydrochloride", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA200022", "marketing_category": "ANDA", "marketing_start_date": "20240220", "listing_expiration_date": "20271231"}