memantine

Generic: memantine

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine
Generic Name memantine
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

memantine hydrochloride 10 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8319
Product ID 0615-8319_f52d94bf-167f-48f1-bc69-37bc8acde5df
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090048
Listing Expiration 2026-12-31
Marketing Start 2015-07-11

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 06158319
Hyphenated Format 0615-8319

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 (source: ndc)
Generic Name memantine (source: ndc)
Application Number ANDA090048 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BLISTER PACK (0615-8319-05)
  • 30 TABLET in 1 BLISTER PACK (0615-8319-39)
source: ndc

Packages (2)

0615-8319-05 15 TABLET in 1 BLISTER PACK (0615-8319-05) 0615-8319-39 30 TABLET in 1 BLISTER PACK (0615-8319-39)

Ingredients (1)

memantine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Memantine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f52d94bf-167f-48f1-bc69-37bc8acde5df", "openfda": {"unii": ["JY0WD0UA60"], "rxcui": ["996561"], "spl_set_id": ["5c8a168d-aef5-4ac7-b8c1-3812a8c228ab"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BLISTER PACK (0615-8319-05)", "package_ndc": "0615-8319-05", "marketing_start_date": "20190903"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-8319-39)", "package_ndc": "0615-8319-39", "marketing_start_date": "20190903"}], "brand_name": "Memantine", "product_id": "0615-8319_f52d94bf-167f-48f1-bc69-37bc8acde5df", "dosage_form": "TABLET", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "0615-8319", "generic_name": "Memantine", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Memantine", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090048", "marketing_category": "ANDA", "marketing_start_date": "20150711", "listing_expiration_date": "20261231"}