memantine hydrochloride

Generic: memantine hydrochloride

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine hydrochloride
Generic Name memantine hydrochloride
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

memantine hydrochloride 5 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3338
Product ID 70518-3338_36462b8b-8138-11a0-e063-6394a90ad027
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090961
Listing Expiration 2026-12-31
Marketing Start 2022-01-20

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 705183338
Hyphenated Format 70518-3338

Supplemental Identifiers

RxCUI
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 ANDA090961 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE, PLASTIC (70518-3338-1)
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-3338-2)
source: ndc

Packages (2)

70518-3338-1 60 TABLET in 1 BOTTLE, PLASTIC (70518-3338-1) 70518-3338-2 90 TABLET in 1 BOTTLE, PLASTIC (70518-3338-2)

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": "36462b8b-8138-11a0-e063-6394a90ad027", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996571"], "spl_set_id": ["cbfd9d95-f50b-45ff-9857-9f1712c45e56"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (70518-3338-1)", "package_ndc": "70518-3338-1", "marketing_start_date": "20250528"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-3338-2)", "package_ndc": "70518-3338-2", "marketing_start_date": "20250528"}], "brand_name": "Memantine Hydrochloride", "product_id": "70518-3338_36462b8b-8138-11a0-e063-6394a90ad027", "dosage_form": "TABLET", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "70518-3338", "generic_name": "Memantine Hydrochloride", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090961", "marketing_category": "ANDA", "marketing_start_date": "20220120", "listing_expiration_date": "20261231"}