FDA.reportPublic FDA data

Ethyol

Product NDC
76310-017
Requested package NDC
76310-017-50
11-digit product format
763100017
Labeler code
76310
Product ID
76310-017_cc8db98c-87bc-461f-8d88-8fbf482c6a3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amifostine
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Clinigen Limited
Application
NDA020221
Marketing category
NDA
Marketing start
2020-01-01
Marketing end
0000-00-00
Substance
AMIFOSTINE
Active strength
500 mg/10mL
Pharmacologic classes
Cytoprotective Agent [EPC], Free Radical Scavenging Activity [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage76310-01776310-017-50DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020221-001ETHYOLAMIFOSTINE500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, RS1995-12-08
N020221-002ETHYOLAMIFOSTINE375MG/VIALINJECTABLE / INJECTION1999-09-10

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020221-001ETHYOL500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INJECTIONRLD, RS1995-12-08a50c72e98297…
2026-08-01 22:54:322026-06N020221-002ETHYOL375MG/VIALINJECTABLE / INJECTION1999-09-10a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EthyolAMIFOSTINELegacy Pharma USA Inc.a17563f2-d231-4385-bc94-0217be78b89d2026-03-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 020221
application number: NDA020221

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76310-017-01EA - Each76310-017259a5cb0-cef5-48df-bb8f-c85ec6f1ee4c12020-02-13
76310-017-50EA - Each76310-017b45ab649-f688-4616-abac-8bf5c43da02f12020-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76310-017-50763100017503 VIAL, SINGLE-USE in 1 CARTON (76310-017-50) > 10 mL in 1 VIAL, SINGLE-USE (76310-017-01) 2020-01-010000-00-00NoNoCurrent