edaravone

Generic: edaravone

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name edaravone
Generic Name edaravone
Labeler sandoz inc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

edaravone 30 mg/100mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3527
Product ID 0781-3527_ae940bc6-1e6a-4b76-825c-bd2e1925e39a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216902
Listing Expiration 2026-12-31
Marketing Start 2025-01-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07813527
Hyphenated Format 0781-3527

Supplemental Identifiers

RxCUI
1924316
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 ANDA216902 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 30 mg/100mL
source: ndc
Packaging
  • 2 BAG in 1 CARTON (0781-3527-20) / 100 mL in 1 BAG (0781-3527-94)
source: ndc

Packages (1)

Ingredients (1)

edaravone (30 mg/100mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "ae940bc6-1e6a-4b76-825c-bd2e1925e39a", "openfda": {"unii": ["S798V6YJRP"], "rxcui": ["1924316"], "spl_set_id": ["ae940bc6-1e6a-4b76-825c-bd2e1925e39a"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BAG in 1 CARTON (0781-3527-20)  / 100 mL in 1 BAG (0781-3527-94)", "package_ndc": "0781-3527-20", "marketing_start_date": "20250121"}], "brand_name": "Edaravone", "product_id": "0781-3527_ae940bc6-1e6a-4b76-825c-bd2e1925e39a", "dosage_form": "INJECTION", "product_ndc": "0781-3527", "generic_name": "Edaravone", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Edaravone", "active_ingredients": [{"name": "EDARAVONE", "strength": "30 mg/100mL"}], "application_number": "ANDA216902", "marketing_category": "ANDA", "marketing_start_date": "20250121", "listing_expiration_date": "20261231"}