FDA.reportPublic FDA data

Topotecan

Product NDC
0409-0302
11-digit product format
004090302
Labeler code
0409
Product ID
0409-0302_293334d4-88f2-4ec2-9eed-20975ff65c0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOPOTECAN
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
NDA200582
Marketing category
NDA
Marketing start
2011-02-21
Substance
TOPOTECAN HYDROCHLORIDE
Active strength
1 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
Topotecan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPOTECAN HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii956S425ZCY
Rxcui1799424

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
cbf6bf79-4ea9-419f-b7df-eefa780730bfProduct name220180125
19c78384-80c8-23c8-a4e6-c197ed91c59eProduct name120140508
302dcbc5-1902-d63c-93ac-bac5e14c2822Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-0302-01Topotecan4 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE423
0409-0302-01Topotecan1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-0302-01ML - Milliliter0409-0302b5b030fb-2afe-47be-91e0-6516d2269e7412012-07-24
0409-0302-25ML - Milliliter0409-0302653caa22-f038-4545-8eaf-ae72ec05c2d912014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPOTECAN HYDROCHLORIDEACTIVE INGREDIENT956S425ZCYTOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]16
TOPOTECANACTIVE MOIETY7M7YKX2N15TOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]16
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBTOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]16
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]16
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HTOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]16
WATERINACTIVE INGREDIENT059QF0KO0RTOPOTECAN (TOPOTECAN HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-0302TOPOTECAN INJECTION, SOLUTION, CONCENTRATE [HOSPIRA, INC.]23Current NDC, Legacy NDC, 2 package rows20210203_1d4e1cce-c57e-4a8b-be96-f95a2778e221.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1799424topotecan 4 MG in 4 ML InjectionPSN1d4e1cce-c57e-4a8b-be96-f95a2778e22123
17994244 ML topotecan 1 MG/ML InjectionSCD1d4e1cce-c57e-4a8b-be96-f95a2778e22123
1799424topotecan (as topotecan hydrochloride) 4 MG per 4 ML InjectionSY1d4e1cce-c57e-4a8b-be96-f95a2778e22123
1799424topotecan 4 MG per 4 ML InjectionSY1d4e1cce-c57e-4a8b-be96-f95a2778e22123

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-0302-01004090302011 VIAL, SINGLE-DOSE in 1 CARTON (0409-0302-01) / 4 mL in 1 VIAL, SINGLE-DOSE2011-02-210000-00-00NoNoCurrent