FDA.reportPublic FDA data

Irinotecan Hydrochloride

Product NDC
60505-6128
11-digit product format
605056128
Labeler code
60505
Product ID
60505-6128_d2676b1a-30fb-456b-bb51-fb76fb64cf2d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA203380
Marketing category
ANDA
Marketing start
2017-11-30
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 Hydrochloride
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-6128-0Irinotecan Hydrochloride1 in 1 CARTONINJECTION, SOLUTION114
60505-6128-0Irinotecan Hydrochloride2 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION214
60505-6128-1Irinotecan Hydrochloride1 in 1 CARTONINJECTION, SOLUTION114
60505-6128-1Irinotecan Hydrochloride5 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6128-0ML - Milliliter60505-61283dcea415-5248-4e51-85d5-3e67165a23b512018-02-20
60505-6128-1ML - Milliliter60505-612858a5aaa9-c937-4e66-bb28-cd8db768a0f212018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6128IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [APOTEX CORP.]14Current NDC, Legacy NDC, 4 package rows20240629_85ed6019-f462-4abe-a89e-ad991623c86d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSN85ed6019-f462-4abe-a89e-ad991623c86d14
1726319irinotecan HCl 40 MG in 2 ML InjectionPSN85ed6019-f462-4abe-a89e-ad991623c86d14
17263192 ML irinotecan hydrochloride 20 MG/ML InjectionSCD85ed6019-f462-4abe-a89e-ad991623c86d14
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCD85ed6019-f462-4abe-a89e-ad991623c86d14
1726324irinotecan HCl 100 MG per 5 ML InjectionSY85ed6019-f462-4abe-a89e-ad991623c86d14
1726319irinotecan HCl 40 MG per 2 ML InjectionSY85ed6019-f462-4abe-a89e-ad991623c86d14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60505-6128-0605056128001 VIAL, SINGLE-USE in 1 CARTON (60505-6128-0) / 2 mL in 1 VIAL, SINGLE-USE2017-11-300000-00-00NoNoCurrent
60505-6128-1605056128011 VIAL, SINGLE-USE in 1 CARTON (60505-6128-1) / 5 mL in 1 VIAL, SINGLE-USE2017-11-300000-00-00NoNoCurrent