FDA.reportPublic FDA data

Irinotecan hydrochloide

Product NDC
68001-480
11-digit product format
680010480
Labeler code
68001
Product ID
68001-480_30b09e30-01bd-efc4-e063-6394a90aabc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan hydrochloide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
BluePoint Laboratories
Application
ANDA212993
Marketing category
ANDA
Marketing start
2020-12-14
Substance
IRINOTECAN HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Irinotecan hydrochloide
Listing expiration
2026-12-31

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
077454e2-2db8-411c-801d-08d70e0bebabProduct name120151116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-480-22Irinotecan hydrochloide1 in 1 CARTONINJECTION17
68001-480-22Irinotecan hydrochloide5 mL in 1 VIAL, SINGLE-DOSEINJECTION57
68001-480-35Irinotecan hydrochloide1 in 1 CARTONINJECTION17
68001-480-35Irinotecan hydrochloide2 mL in 1 VIAL, SINGLE-DOSEINJECTION27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-480-22ML - Milliliter68001-480afb7171e-938d-4e79-b984-72359dc01d7e12021-03-02
68001-480-35ML - Milliliter68001-480c1d75f04-13cb-4eda-aed9-3b8ebe8942a012021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-480IRINOTECAN HYDROCHLOIDE INJECTION [BLUEPOINT LABORATORIES]7Current NDC, Legacy NDC, 4 package rows20250322_b66dbd6d-6ccb-ce9d-e053-2995a90a4c3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSNb66dbd6d-6ccb-ce9d-e053-2995a90a4c3c7
1726319irinotecan HCl 40 MG in 2 ML InjectionPSNb66dbd6d-6ccb-ce9d-e053-2995a90a4c3c7
17263192 ML irinotecan hydrochloride 20 MG/ML InjectionSCDb66dbd6d-6ccb-ce9d-e053-2995a90a4c3c7
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCDb66dbd6d-6ccb-ce9d-e053-2995a90a4c3c7
1726324irinotecan HCl 100 MG per 5 ML InjectionSYb66dbd6d-6ccb-ce9d-e053-2995a90a4c3c7
1726319irinotecan HCl 40 MG per 2 ML InjectionSYb66dbd6d-6ccb-ce9d-e053-2995a90a4c3c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-480-22680010480221 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-22) / 5 mL in 1 VIAL, SINGLE-DOSE2020-12-140000-00-00NoNoCurrent
68001-480-35680010480351 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-35) / 2 mL in 1 VIAL, SINGLE-DOSE2020-12-140000-00-00NoNoCurrent