edaravone

Generic: edaravone

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name edaravone
Generic Name edaravone
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

edaravone 60 mg/100mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-501
Product ID 68083-501_57566e6e-e90a-4fdf-b23c-d8af19893fd2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216199
Listing Expiration 2026-12-31
Marketing Start 2024-05-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083501
Hyphenated Format 68083-501

Supplemental Identifiers

RxCUI
1924316 2681044
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 ANDA216199 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/100mL
source: ndc
Packaging
  • 1 POUCH in 1 CARTON (68083-501-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG
source: ndc

Packages (1)

68083-501-01 1 POUCH in 1 CARTON (68083-501-01) / 1 BAG in 1 POUCH / 100 mL in 1 BAG

Ingredients (1)

edaravone (60 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": "57566e6e-e90a-4fdf-b23c-d8af19893fd2", "openfda": {"unii": ["S798V6YJRP"], "rxcui": ["1924316", "2681044"], "spl_set_id": ["46452eb5-db17-400d-b25b-11844a11e711"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 POUCH in 1 CARTON (68083-501-01)  / 1 BAG in 1 POUCH / 100 mL in 1 BAG", "package_ndc": "68083-501-01", "marketing_start_date": "20240506"}], "brand_name": "edaravone", "product_id": "68083-501_57566e6e-e90a-4fdf-b23c-d8af19893fd2", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "68083-501", "generic_name": "edaravone", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "edaravone", "active_ingredients": [{"name": "EDARAVONE", "strength": "60 mg/100mL"}], "application_number": "ANDA216199", "marketing_category": "ANDA", "marketing_start_date": "20240506", "listing_expiration_date": "20261231"}