RADICAVA

Product NDC
70510-2171
11-digit product format
705102171
Labeler code
70510
Product ID
70510-2171_5568c252-2a53-4307-8961-063865500fc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EDARAVONE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Mitsubishi Tanabe Pharma America, Inc.
Application
NDA209176
Marketing category
NDA
Marketing start
2017-05-05
Marketing end
0000-00-00
Substance
EDARAVONE
Active strength
30 mg/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
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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
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c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70510-2171-22020-03-12C16284748780-19d75b9cf-cdbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS . RADICAVA® (edaravone) injection, for intravenous use RADICAVA ORS® (edaravone) oral suspension Initial U.S. Approval: 2017
70510-2171-22020-03-12C16284748780-19d75b9cf-cdbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS. RADICAVA ® (edaravone) injection, for intravenous use RADICAVA ORS ® (edaravone) oral suspension Initial U.S. Approval: 2017
70510-2171-22020-03-12C16284748780-19d75b9cf-cdbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS . RADICAVA® (edaravone) injection, for intravenous use RADICAVA ORS® (edaravone) oral suspension Initial U.S. Approval: 2017
70510-2171-22020-01-31C16284748780-19d75b9cf-cdbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS . RADICAVA® (edaravone) injection, for intravenous use RADICAVA ORS® (edaravone) oral suspension Initial U.S. Approval: 2017
70510-2171-22020-01-31C16284748780-19d75b9cf-cdbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS. RADICAVA ® (edaravone) injection, for intravenous use RADICAVA ORS ® (edaravone) oral suspension Initial U.S. Approval: 2017
70510-2171-22020-01-31C16284748780-19d75b9cf-cdbb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use RADICAVA or RADICAVA ORS safely and effectively. See full prescribing information for RADICAVA or RADICAVA ORS . RADICAVA® (edaravone) injection, for intravenous use RADICAVA ORS® (edaravone) oral suspension Initial U.S. Approval: 2017

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70510-2171-1RADICAVA100 mL in 1 BAGINJECTION10029
70510-2171-2RADICAVA2 in 1 CARTONINJECTION229

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70510-2171-1ML - Milliliter70510-21712f6a6236-deaa-4b97-bb50-a7ff734ed1b212017-06-15
70510-2171-2ML - Milliliter70510-217155c52454-7ae7-4bf0-aa56-455b980ca26a12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70510-2171RADICAVA (EDARAVONE) INJECTION RADICAVA ORS (EDARAVONE) KIT [MITSUBISHI TANABE PHARMA AMERICA, INC.]24Legacy NDC, 2 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
70510-2171-170510217101100 mL in 1 BAG100 mlHistorical
70510-2171-2705102171022 BAG in 1 CARTON (70510-2171-2) > 100 mL in 1 BAG (70510-2171-1) 2 bag2017-05-050000-00-00NoNoCurrent