memantine hydrochloride

Generic: memantine hydrochloride

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

Drug Facts

Product Profile

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

memantine hydrochloride 10 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8647
Product ID 68788-8647_49c19bbd-4d60-4f50-9cec-62b0074ffd08
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206528
Listing Expiration 2026-12-31
Marketing Start 2024-05-01

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 687888647
Hyphenated Format 68788-8647

Supplemental Identifiers

RxCUI
996561
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 ANDA206528 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68788-8647-3)
  • 60 TABLET in 1 BOTTLE (68788-8647-6)
  • 90 TABLET in 1 BOTTLE (68788-8647-9)
source: ndc

Packages (3)

68788-8647-3 30 TABLET in 1 BOTTLE (68788-8647-3) 68788-8647-6 60 TABLET in 1 BOTTLE (68788-8647-6) 68788-8647-9 90 TABLET in 1 BOTTLE (68788-8647-9)

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": "49c19bbd-4d60-4f50-9cec-62b0074ffd08", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996561"], "spl_set_id": ["becb09dc-174d-4817-88d4-f38c8adcd309"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8647-3)", "package_ndc": "68788-8647-3", "marketing_start_date": "20240501"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8647-6)", "package_ndc": "68788-8647-6", "marketing_start_date": "20240501"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8647-9)", "package_ndc": "68788-8647-9", "marketing_start_date": "20240501"}], "brand_name": "Memantine Hydrochloride", "product_id": "68788-8647_49c19bbd-4d60-4f50-9cec-62b0074ffd08", "dosage_form": "TABLET", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "68788-8647", "generic_name": "Memantine Hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine Hydrochloride", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA206528", "marketing_category": "ANDA", "marketing_start_date": "20240501", "listing_expiration_date": "20261231"}