FDA.reportPublic FDA data

Irinotecan hydrochloide

Product NDC
68083-381
11-digit product format
680830381
Labeler code
68083
Product ID
68083-381_a1ced9af-9117-485c-925d-47f7266bc9df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan hydrochloide
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
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
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
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
68083-381-01Irinotecan hydrochloide1 in 1 CARTONINJECTION110
68083-381-01Irinotecan hydrochloide2 mL in 1 VIAL, SINGLE-DOSEINJECTION210

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-381IRINOTECAN HYDROCHLOIDE INJECTION IRINOTECAN HYDROCHLORIDE INJECTION [GLAND PHARMA LIMITED]10Current NDC, Legacy NDC, 2 package rows20220304_de634e80-328a-4473-b395-0172683a2411.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSNde634e80-328a-4473-b395-0172683a241110
1726319irinotecan HCl 40 MG in 2 ML InjectionPSNde634e80-328a-4473-b395-0172683a241110
17263192 ML irinotecan hydrochloride 20 MG/ML InjectionSCDde634e80-328a-4473-b395-0172683a241110
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCDde634e80-328a-4473-b395-0172683a241110
1726324irinotecan HCl 100 MG per 5 ML InjectionSYde634e80-328a-4473-b395-0172683a241110
1726319irinotecan HCl 40 MG per 2 ML InjectionSYde634e80-328a-4473-b395-0172683a241110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68083-381-01680830381011 VIAL, SINGLE-DOSE in 1 CARTON (68083-381-01) / 2 mL in 1 VIAL, SINGLE-DOSE2019-11-180000-00-00NoNoCurrent