FDA.reportPublic FDA data

Irinotecan Hydrochloride

Product NDC
59923-715
11-digit product format
599230715
Labeler code
59923
Product ID
59923-715_b8e4461e-df60-aa36-e053-2a95a90af916
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Areva Pharmaceuticals, Inc.
Application
ANDA208718
Marketing category
ANDA
Marketing start
2019-03-01
Marketing end
0000-00-00
Substance
IRINOTECAN HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cfce77d6-e90b-6280-14b8-e6a66a38ebbcProduct name720210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
077454e2-2db8-411c-801d-08d70e0bebabProduct name120151116
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59923-715-052024-01-30C16284748780-11030e365-4a8a-111a-e063-dadaa90a10e2HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use IRINOTECAN HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for IRINOTECAN HYDROCHLORIDE INJECTION. IRINOTECAN HYDROCHLORIDE injection, for intravenous use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59923-715-05Irinotecan Hydrochloride1 in 1 CARTONINJECTION15
59923-715-05Irinotecan Hydrochloride5 mL in 1 VIALINJECTION55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59923-715-05ML - Milliliter59923-71536352d58-d637-4b39-9849-81135ee4bfef12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59923-715IRINOTECAN HYDROCHLORIDE INJECTION [AREVA PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20210115_82e95139-6222-f73d-e053-2a91aa0a4810.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSN82e95139-6222-f73d-e053-2a91aa0a48105
1726333irinotecan HCl 300 MG in 15 ML InjectionPSN82e95139-6222-f73d-e053-2a91aa0a48105
1726319irinotecan HCl 40 MG in 2 ML InjectionPSN82e95139-6222-f73d-e053-2a91aa0a48105
172633315 ML irinotecan hydrochloride 20 MG/ML InjectionSCD82e95139-6222-f73d-e053-2a91aa0a48105
17263192 ML irinotecan hydrochloride 20 MG/ML InjectionSCD82e95139-6222-f73d-e053-2a91aa0a48105
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCD82e95139-6222-f73d-e053-2a91aa0a48105
1726324irinotecan HCl 100 MG per 5 ML InjectionSY82e95139-6222-f73d-e053-2a91aa0a48105
1726333irinotecan HCl 300 MG per 15 ML InjectionSY82e95139-6222-f73d-e053-2a91aa0a48105
1726319irinotecan HCl 40 MG per 2 ML InjectionSY82e95139-6222-f73d-e053-2a91aa0a48105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59923-715-05599230715051 VIAL in 1 CARTON (59923-715-05) > 5 mL in 1 VIAL1 vial2019-03-010000-00-00NoNoCurrent