FDA.reportPublic FDA data

Irinotecan Hydrochloride

Product NDC
0143-9702
11-digit product format
001439702
Labeler code
0143
Product ID
0143-9702_204eb37a-642f-4321-9466-414c32a6bbce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA091032
Marketing category
ANDA
Marketing start
2010-12-20
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
0143-9702-01Irinotecan Hydrochloride2 mL in 1 VIAL, GLASSINJECTION29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9702-01ML - Milliliter0143-9702a5d2b79d-69df-45ba-9539-15ae6ed7439e12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IRINOTECAN HYDROCHLORIDEACTIVE INGREDIENT042LAQ1IISIRINOTECAN HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]6
IRINOTECANACTIVE MOIETY7673326042IRINOTECAN HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]6
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBIRINOTECAN HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]6
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATIRINOTECAN HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IIRINOTECAN HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]6
SORBITOLINACTIVE INGREDIENT506T60A25RIRINOTECAN HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]6
WATERINACTIVE INGREDIENT059QF0KO0RIRINOTECAN HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9702IRINOTECAN HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]9Current NDC, Legacy NDC, 1 package rows20220818_be716692-6b4f-47b6-83d1-01665861626b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSNbe716692-6b4f-47b6-83d1-01665861626b9
1726319irinotecan HCl 40 MG in 2 ML InjectionPSNbe716692-6b4f-47b6-83d1-01665861626b9
17263192 ML irinotecan hydrochloride 20 MG/ML InjectionSCDbe716692-6b4f-47b6-83d1-01665861626b9
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCDbe716692-6b4f-47b6-83d1-01665861626b9
1726324irinotecan HCl 100 MG per 5 ML InjectionSYbe716692-6b4f-47b6-83d1-01665861626b9
1726319irinotecan HCl 40 MG per 2 ML InjectionSYbe716692-6b4f-47b6-83d1-01665861626b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9702-01001439702012 mL in 1 VIAL, GLASS (0143-9702-01) 2 ml2010-12-200000-00-00NoNoCurrent