Home NDC 0781-3527 Edaravone
Product NDC 0781-3527
11-digit product format 007813527
Labeler code 0781
Product ID 0781-3527_ae940bc6-1e6a-4b76-825c-bd2e1925e39a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Edaravone
Dosage form INJECTION
Route INTRAVENOUS
Labeler Sandoz Inc
Application ANDA216902
Marketing category ANDA
Marketing start 2025-01-21
Substance EDARAVONE
Active strength 30 mg/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216902-001 EDARAVONE EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216902-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A216902-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216902-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216902-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216902-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216902-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216902-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216902-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-12-23 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216902-001 EDARAVONE 30MG/100ML (0.3MG/ML) SOLUTION / INTRAVENOUS AP 2024-12-23 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Edaravone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EDARAVONE 30 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S798V6YJRP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1924316 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-3527-20 Edaravone 2 in 1 CARTON INJECTION 2 1 0781-3527-94 Edaravone 100 mL in 1 BAG INJECTION 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3527 EDARAVONE INJECTION [SANDOZ INC] 1 Current NDC, 2 package rows 20250121_ae940bc6-1e6a-4b76-825c-bd2e1925e39a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0781-3527-20 00781352720 2 BAG in 1 CARTON (0781-3527-20) / 100 mL in 1 BAG (0781-3527-94) 2 bag 2025-01-21 No No Current 0781-3527-94 00781352794 100 mL in 1 BAG 100 ml Historical