FDA.reportPublic FDA data

Irinotecan hydrochloide

Product NDC
70700-169
11-digit product format
707000169
Labeler code
70700
Product ID
70700-169_4b364426-00fb-0ef1-e063-6394a90aaba6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan hydrochloide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Xiromed LLC
Application
ANDA212993
Marketing category
ANDA
Marketing start
2019-11-18
Substance
IRINOTECAN HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Irinotecan hydrochloide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRINOTECAN HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii042LAQ1IIS
Rxcui1726319, 1726324

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
70700-169-222026-01-29C16284748780-149896155-b97f-586f-e063-e6dba90add90These 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
70700-169-22Irinotecan hydrochloide1 in 1 CARTONINJECTION113
70700-169-22Irinotecan hydrochloide2 mL in 1 VIAL, SINGLE-DOSEINJECTION213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-169-22ML - Milliliter70700-169e9453189-3aa7-46ac-b3e0-114a9066fa5912020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-169IRINOTECAN HYDROCHLOIDE INJECTION IRINOTECAN HYDROCHLORIDE INJECTION [XIROMED LLC]10Current NDC, Legacy NDC, 2 package rows20220331_b26e5d27-dba5-7538-9e7b-48b358998cbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSNb26e5d27-dba5-7538-9e7b-48b358998cbb13
1726319irinotecan HCl 40 MG in 2 ML InjectionPSNb26e5d27-dba5-7538-9e7b-48b358998cbb13
17263192 ML irinotecan hydrochloride 20 MG/ML InjectionSCDb26e5d27-dba5-7538-9e7b-48b358998cbb13
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCDb26e5d27-dba5-7538-9e7b-48b358998cbb13
1726324irinotecan HCl 100 MG per 5 ML InjectionSYb26e5d27-dba5-7538-9e7b-48b358998cbb13
1726319irinotecan HCl 40 MG per 2 ML InjectionSYb26e5d27-dba5-7538-9e7b-48b358998cbb13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70700-169-22707000169221 VIAL, SINGLE-DOSE in 1 CARTON (70700-169-22) / 2 mL in 1 VIAL, SINGLE-DOSE2019-11-180000-00-00NoNoCurrent