FDA.reportPublic FDA data

RADICAVA ORS

Product NDC
70510-2321
11-digit product format
705102321
Labeler code
70510
Product ID
70510-2321_9f9d17c0-7426-4713-885d-fb22a34b7028
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EDARAVONE
Dosage form
KIT
Labeler
Shionogi Inc.
Application
NDA215446
Marketing category
NDA
Marketing start
2022-05-12
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RADICAVA ORS
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui1924316, 1924317, 2602117, 2602122

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
385a0d1f-d345-4dbf-ab81-b84027f8102fProduct name320250218
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70510-2321-1RADICAVA ORS1 in 1 CARTONKIT129
70510-2321-2RADICAVA ORS2 in 1 CARTONKIT229
70510-2323-1RADICAVA ORS1 in 1 KITSUSPENSION735 mg in 35mL29
70510-2323-1RADICAVA ORS35 mL in 1 BOTTLESUSPENSION1 mL735 mg in 35mL29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70510-2321-1ML - Milliliter70510-2321aa82fdcb-4911-4874-8e74-56964815cf9312022-06-06
70510-2321-2ML - Milliliter70510-23211bf4f377-482c-4000-a2d9-3ac511909f9912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70510-2321RADICAVA (EDARAVONE) INJECTION RADICAVA ORS (EDARAVONE) KIT [MITSUBISHI TANABE PHARMA AMERICA, INC.]24Current NDC, Legacy NDC, 4 package rows20250305_0ce2c1c4-2a40-485c-b7cb-96a9b85d9d11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2602117edaravone 21 MG/mL Oral SuspensionPSN0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
1924316edaravone 30 MG in 100 ML InjectionPSN0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
1924317Radicava 30 MG in 100 ML InjectionPSN0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
2602122Radicava ORS 21 MG/mL Oral SuspensionPSN0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
1924317100 ML edaravone 0.3 MG/ML Injection [Radicava]SBD0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
2602122edaravone 21 MG/ML Oral Suspension [Radicava]SBD0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
1924316100 ML edaravone 0.3 MG/ML InjectionSCD0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
2602117edaravone 21 MG/ML Oral SuspensionSCD0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
1924317100 ML Radicava 0.3 MG/ML InjectionSY0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
2602117edaravone 1050 MG per 50 ML Oral SuspensionSY0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
1924316edaravone 30 MG per 100 ML InjectionSY0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
2602117edaravone 735 MG per 35 ML Oral SuspensionSY0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
1924317Radicava 30 MG per 100 ML InjectionSY0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
2602122Radicava ORS 1050 MG per 50 ML Oral SuspensionSY0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
2602122Radicava ORS 21 MG/ML Oral SuspensionSY0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129
2602122Radicava ORS 735 MG per 35 ML Oral SuspensionSY0ce2c1c4-2a40-485c-b7cb-96a9b85d9d1129

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70510-2321-1705102321011 in 1 CARTONHistorical
70510-2321-2705102321022 CARTON in 1 CARTON (70510-2321-2) / 1 KIT in 1 CARTON (70510-2321-1) * 1 BOTTLE in 1 KIT (70510-2323-1) / 35 mL in 1 BOTTLE2 carton2022-05-120000-00-00NoNoCurrent
70510-2323-1705102323011 in 1 KITHistorical