FDA.reportPublic FDA data

Irinotecan Hydrochloride

Product NDC
72485-212
11-digit product format
724850212
Labeler code
72485
Product ID
72485-212_e1309129-c950-48ba-b8af-a952d5b3bed3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Irinotecan Hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Armas Pharmaceuticals Inc.
Application
ANDA208718
Marketing category
ANDA
Marketing start
2019-04-01
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
Brand name suffix
100 mg/5 mL
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
077454e2-2db8-411c-801d-08d70e0bebabProduct name120151116
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-212-05Irinotecan Hydrochloride100 mg/5 mL5 mL in 1 VIALINJECTION52
72485-212-05Irinotecan Hydrochloride100 mg/5 mL1 in 1 CARTONINJECTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-212-05ML - Milliliter72485-2122a9ebdaa-ee67-43c4-918a-487b30087daf12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-212IRINOTECAN HYDROCHLORIDE 100 MG/5 ML (IRINOTECAN HYDROCHLORIDE) INJECTION [ARMAS PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20200908_2f160344-4ec6-4285-b293-86c0dd40d8b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSN2f160344-4ec6-4285-b293-86c0dd40d8b52
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCD2f160344-4ec6-4285-b293-86c0dd40d8b52
1726324irinotecan HCl 100 MG per 5 ML InjectionSY2f160344-4ec6-4285-b293-86c0dd40d8b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72485-212-05724850212051 VIAL in 1 CARTON (72485-212-05) / 5 mL in 1 VIAL1 vial2019-04-010000-00-00NoNoCurrent