memantine

Generic: memantine

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name memantine
Generic Name memantine
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

memantine hydrochloride 5 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-895
Product ID 62135-895_f3ba0986-42cf-a016-e053-2995a90a7c9f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090244
Listing Expiration 2026-12-31
Marketing Start 2018-07-11

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 62135895
Hyphenated Format 62135-895

Supplemental Identifiers

RxCUI
996561 996571
UPC
0362135895600 0362135896607
UNII
JY0WD0UA60

Packaging Origin

Original Packager
true

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 ANDA090244 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (62135-895-60)
source: ndc

Packages (1)

62135-895-60 60 TABLET in 1 BOTTLE (62135-895-60)

Ingredients (1)

memantine hydrochloride (5 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": "f3ba0986-42cf-a016-e053-2995a90a7c9f", "openfda": {"upc": ["0362135895600", "0362135896607"], "unii": ["JY0WD0UA60"], "rxcui": ["996561", "996571"], "spl_set_id": ["6906b0b4-1944-40f0-844a-e0db72ba4675"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (62135-895-60)", "package_ndc": "62135-895-60", "marketing_start_date": "20230201"}], "brand_name": "memantine", "product_id": "62135-895_f3ba0986-42cf-a016-e053-2995a90a7c9f", "dosage_form": "TABLET", "pharm_class": ["N-methyl-D-aspartate Receptor Antagonist [EPC]", "NMDA Receptor Antagonists [MoA]"], "product_ndc": "62135-895", "generic_name": "memantine", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "memantine", "active_ingredients": [{"name": "MEMANTINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA090244", "marketing_category": "ANDA", "marketing_start_date": "20180711", "listing_expiration_date": "20261231"}