FDA.reportPublic FDA data

Topotecan hydrochloride

Product NDC
45963-615
11-digit product format
459630615
Labeler code
45963
Product ID
45963-615_0edbf531-9ae9-4f9d-a606-f8f56768ce9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topotecan hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Actavis Pharma, Inc.
Application
ANDA090620
Marketing category
ANDA
Marketing start
2015-01-05
Substance
TOPOTECAN HYDROCHLORIDE
Active strength
4 mg/4mL
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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPOTECAN HYDROCHLORIDE4 mg/4mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii956S425ZCY
Rxcui1799416

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
45963-615-56Topotecan hydrochloride4 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,410
45963-615-56Topotecan hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-615-56EA - Each45963-615b26a9c38-de5a-4b9f-a1cc-d03d9be666e012015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPOTECAN HYDROCHLORIDEACTIVE INGREDIENT956S425ZCYTOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.]5
TOPOTECANACTIVE MOIETY7M7YKX2N15TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.]5
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBTOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ATOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.]5
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HTOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45963-615TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTAVIS PHARMA, INC.]10Current NDC, Legacy NDC, 2 package rows20221122_996430c0-ee26-4ed9-82b8-a8b645becba6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1799416topotecan 4 MG InjectionPSN996430c0-ee26-4ed9-82b8-a8b645becba610
1799416topotecan 4 MG InjectionSCD996430c0-ee26-4ed9-82b8-a8b645becba610
1799416topotecan (as topotecan hydrochloride) 4 MG InjectionSY996430c0-ee26-4ed9-82b8-a8b645becba610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45963-615-56459630615561 VIAL in 1 CARTON (45963-615-56) / 4 mL in 1 VIAL1 vial2015-01-050000-00-00NoNoCurrent