FDA.reportPublic FDA data

Irinotecan Hydrochloride

Product NDC
50742-401
11-digit product format
507420401
Labeler code
50742
Product ID
50742-401_3c841594-8a93-4728-b184-0f4bfac73390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA206935
Marketing category
ANDA
Marketing start
2017-06-05
Substance
IRINOTECAN HYDROCHLORIDE
Active strength
40 mg/2mL
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 HYDROCHLORIDE40 mg/2mL

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
50742-401-02Irinotecan Hydrochloride2 mL in 1 VIAL, GLASSINJECTION213
50742-401-02Irinotecan Hydrochloride1 in 1 CARTONINJECTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-401-02ML - Milliliter50742-401df9b650a-bb11-414a-9f32-8c87ab2d66bd12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-401IRINOTECAN HYDROCHLORIDE INJECTION [INGENUS PHARMACEUTICALS, LLC]12Current NDC, Legacy NDC, 2 package rows20221124_d04f2471-3085-4fc8-a657-bb3918d48e6e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSNd04f2471-3085-4fc8-a657-bb3918d48e6e13
1726319irinotecan HCl 40 MG in 2 ML InjectionPSNd04f2471-3085-4fc8-a657-bb3918d48e6e13
17263192 ML irinotecan hydrochloride 20 MG/ML InjectionSCDd04f2471-3085-4fc8-a657-bb3918d48e6e13
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCDd04f2471-3085-4fc8-a657-bb3918d48e6e13
1726324irinotecan HCl 100 MG per 5 ML InjectionSYd04f2471-3085-4fc8-a657-bb3918d48e6e13
1726319irinotecan HCl 40 MG per 2 ML InjectionSYd04f2471-3085-4fc8-a657-bb3918d48e6e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-401-02507420401021 VIAL, GLASS in 1 CARTON (50742-401-02) / 2 mL in 1 VIAL, GLASS2017-06-050000-00-00NoNoCurrent