FDA.reportPublic FDA data

IRINOTECAN HYDROCHLORIDE

Product NDC
55150-352
11-digit product format
551500352
Labeler code
55150
Product ID
55150-352_2fc24d11-bf17-4007-8a65-d949793a972e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IRINOTECAN HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA213278
Marketing category
ANDA
Marketing start
2020-02-11
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, 1726333

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cfce77d6-e90b-6280-14b8-e6a66a38ebbcProduct name720210525
077454e2-2db8-411c-801d-08d70e0bebabProduct name120151116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-352-01IRINOTECAN HYDROCHLORIDE2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION24
55150-352-01IRINOTECAN HYDROCHLORIDE1 in 1 CARTONINJECTION, SOLUTION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-352-01ML - Milliliter55150-35243072be9-eccf-40ec-b0e8-899f07fb689612021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-352IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC]3Current NDC, Legacy NDC, 2 package rows20230731_7a30d551-9ea7-47ea-9073-f541bff457a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726324irinotecan HCl 100 MG in 5 ML InjectionPSN7a30d551-9ea7-47ea-9073-f541bff457a34
1726333irinotecan HCl 300 MG in 15 ML InjectionPSN7a30d551-9ea7-47ea-9073-f541bff457a34
1726319irinotecan HCl 40 MG in 2 ML InjectionPSN7a30d551-9ea7-47ea-9073-f541bff457a34
172633315 ML irinotecan hydrochloride 20 MG/ML InjectionSCD7a30d551-9ea7-47ea-9073-f541bff457a34
17263192 ML irinotecan hydrochloride 20 MG/ML InjectionSCD7a30d551-9ea7-47ea-9073-f541bff457a34
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCD7a30d551-9ea7-47ea-9073-f541bff457a34
1726324irinotecan HCl 100 MG per 5 ML InjectionSY7a30d551-9ea7-47ea-9073-f541bff457a34
1726333irinotecan HCl 300 MG per 15 ML InjectionSY7a30d551-9ea7-47ea-9073-f541bff457a34
1726319irinotecan HCl 40 MG per 2 ML InjectionSY7a30d551-9ea7-47ea-9073-f541bff457a34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-352-01551500352011 VIAL, SINGLE-DOSE in 1 CARTON (55150-352-01) / 2 mL in 1 VIAL, SINGLE-DOSE2020-02-110000-00-00NoNoCurrent