edaravone

Generic: edaravone

Labeler: xgen pharmaceuticals djb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name edaravone
Generic Name edaravone
Labeler xgen pharmaceuticals djb, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

edaravone 30 mg/100mL

Manufacturer
XGen Pharmaceuticals DJB, Inc.

Identifiers & Regulatory

Product NDC 39822-4500
Product ID 39822-4500_316d0e19-cb92-1e55-e063-6294a90ab687
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217565
Listing Expiration 2026-12-31
Marketing Start 2024-12-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 398224500
Hyphenated Format 39822-4500

Supplemental Identifiers

RxCUI
1924316 2681044
UPC
0339822451012 0339822450015
UNII
S798V6YJRP

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 edaravone (source: ndc)
Generic Name edaravone (source: ndc)
Application Number ANDA217565 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/100mL
source: ndc
Packaging
  • 2 VIAL, SINGLE-DOSE in 1 CARTON (39822-4500-2) / 100 mL in 1 VIAL, SINGLE-DOSE (39822-4500-1)
source: ndc

Packages (1)

39822-4500-2 2 VIAL, SINGLE-DOSE in 1 CARTON (39822-4500-2) / 100 mL in 1 VIAL, SINGLE-DOSE (39822-4500-1)

Ingredients (1)

edaravone (30 mg/100mL)

Linked Drug Pages (1)

edaravone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "316d0e19-cb92-1e55-e063-6294a90ab687", "openfda": {"upc": ["0339822451012", "0339822450015"], "unii": ["S798V6YJRP"], "rxcui": ["1924316", "2681044"], "spl_set_id": ["a8245a98-2ccb-4062-b865-3aa348351b48"], "manufacturer_name": ["XGen Pharmaceuticals DJB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 VIAL, SINGLE-DOSE in 1 CARTON (39822-4500-2)  / 100 mL in 1 VIAL, SINGLE-DOSE (39822-4500-1)", "package_ndc": "39822-4500-2", "marketing_start_date": "20241202"}], "brand_name": "edaravone", "product_id": "39822-4500_316d0e19-cb92-1e55-e063-6294a90ab687", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "39822-4500", "generic_name": "edaravone", "labeler_name": "XGen Pharmaceuticals DJB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "edaravone", "active_ingredients": [{"name": "EDARAVONE", "strength": "30 mg/100mL"}], "application_number": "ANDA217565", "marketing_category": "ANDA", "marketing_start_date": "20241202", "listing_expiration_date": "20261231"}