FDA.reportPublic FDA data

Camptosar

Product NDC
0009-0112
11-digit product format
000090112
Labeler code
0009
Product ID
0009-0112_6f05fe24-191a-4273-ad62-4ab6b5324062
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
irinotecan hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA020571
Marketing category
NDA
Marketing start
2024-12-30
Substance
IRINOTECAN HYDROCHLORIDE
Active strength
20 mg/mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Camptosar
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRINOTECAN HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii042LAQ1IIS
Rxcui1726319, 1726321, 1726324, 1726325, 1726333, 1726335

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
0009-0112-05Camptosar1 in 1 CARTONINJECTION, SOLUTION137
0009-0112-05Camptosar5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION537

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0112-05ML - Milliliter0009-0112bacea2b8-23a5-4387-a2f9-135ac91114c912025-01-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IRINOTECAN HYDROCHLORIDEACTIVE INGREDIENT042LAQ1IISCAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]20
IRINOTECANACTIVE MOIETY7673326042CAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]20
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]20
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATCAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]20
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY]20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0112CAMPTOSAR (IRINOTECAN HYDROCHLORIDE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]34Current NDC, 2 package rows20250101_e518dfc6-7e93-4fee-a66c-51e1ab71c056.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1726325Camptosar 100 MG in 5 ML InjectionPSNe518dfc6-7e93-4fee-a66c-51e1ab71c05637
1726335Camptosar 300 MG in 15 ML InjectionPSNe518dfc6-7e93-4fee-a66c-51e1ab71c05637
1726321Camptosar 40 MG in 2 ML InjectionPSNe518dfc6-7e93-4fee-a66c-51e1ab71c05637
1726324irinotecan HCl 100 MG in 5 ML InjectionPSNe518dfc6-7e93-4fee-a66c-51e1ab71c05637
1726333irinotecan HCl 300 MG in 15 ML InjectionPSNe518dfc6-7e93-4fee-a66c-51e1ab71c05637
1726319irinotecan HCl 40 MG in 2 ML InjectionPSNe518dfc6-7e93-4fee-a66c-51e1ab71c05637
172633515 ML irinotecan hydrochloride 20 MG/ML Injection [Camptosar]SBDe518dfc6-7e93-4fee-a66c-51e1ab71c05637
17263212 ML irinotecan hydrochloride 20 MG/ML Injection [Camptosar]SBDe518dfc6-7e93-4fee-a66c-51e1ab71c05637
17263255 ML irinotecan hydrochloride 20 MG/ML Injection [Camptosar]SBDe518dfc6-7e93-4fee-a66c-51e1ab71c05637
172633315 ML irinotecan hydrochloride 20 MG/ML InjectionSCDe518dfc6-7e93-4fee-a66c-51e1ab71c05637
17263192 ML irinotecan hydrochloride 20 MG/ML InjectionSCDe518dfc6-7e93-4fee-a66c-51e1ab71c05637
17263245 ML irinotecan hydrochloride 20 MG/ML InjectionSCDe518dfc6-7e93-4fee-a66c-51e1ab71c05637
172633515 ML Camptosar 20 MG/ML InjectionSYe518dfc6-7e93-4fee-a66c-51e1ab71c05637
17263212 ML Camptosar 20 MG/ML InjectionSYe518dfc6-7e93-4fee-a66c-51e1ab71c05637
17263255 ML Camptosar 20 MG/ML InjectionSYe518dfc6-7e93-4fee-a66c-51e1ab71c05637
1726325Camptosar 100 MG per 5 ML InjectionSYe518dfc6-7e93-4fee-a66c-51e1ab71c05637
1726335Camptosar 300 MG per 15 ML InjectionSYe518dfc6-7e93-4fee-a66c-51e1ab71c05637
1726321Camptosar 40 MG per 2 ML InjectionSYe518dfc6-7e93-4fee-a66c-51e1ab71c05637
1726324irinotecan HCl 100 MG per 5 ML InjectionSYe518dfc6-7e93-4fee-a66c-51e1ab71c05637
1726333irinotecan HCl 300 MG per 15 ML InjectionSYe518dfc6-7e93-4fee-a66c-51e1ab71c05637
1726319irinotecan HCl 40 MG per 2 ML InjectionSYe518dfc6-7e93-4fee-a66c-51e1ab71c05637

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0009-0112-05000090112051 VIAL, SINGLE-DOSE in 1 CARTON (0009-0112-05) / 5 mL in 1 VIAL, SINGLE-DOSE2024-12-30NoNoCurrent