FDA.reportPublic FDA data

Irinotecan Hydrochloride

Product NDC
60505-6272
11-digit product format
605056272
Labeler code
60505
Product ID
60505-6272_c313857d-e43f-4500-8766-6037fb68ad9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan Hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Apotex Corp.
Application
ANDA203380
Marketing category
ANDA
Marketing start
2023-07-01
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
Rxcui1726324

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
60505-6272-1Irinotecan Hydrochloride1 in 1 CARTONINJECTION, SOLUTION12
60505-6272-1Irinotecan Hydrochloride5 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-6272-1ML - Milliliter60505-627293557945-1f4d-4a7f-b36d-ec59dd69355112023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-6272IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [APOTEX CORP.]1Current NDC, 2 package rows20230701_8fe98987-e526-4729-a8f4-c7230f424108.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSN8fe98987-e526-4729-a8f4-c7230f4241082
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCD8fe98987-e526-4729-a8f4-c7230f4241082
1726324irinotecan HCl 100 MG per 5 ML InjectionSY8fe98987-e526-4729-a8f4-c7230f4241082

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60505-6272-1605056272011 VIAL, SINGLE-USE in 1 CARTON (60505-6272-1) / 5 mL in 1 VIAL, SINGLE-USE2023-07-01NoNoCurrent