FDA.reportPublic FDA data

Topotecan Hydrochloride

Product NDC
55390-370
11-digit product format
553900370
Labeler code
55390
Product ID
55390-370_654d0d44-73a6-baa4-78ec-8fa492237dab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topotecan Hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Bedford Laboratories
Application
ANDA201191
Marketing category
ANDA
Marketing start
2011-04-18
Marketing end
0000-00-00
Substance
TOPOTECAN HYDROCHLORIDE
Active strength
4 mg/4mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55390-370IInactivated by FDA2026-07-31
excluded packagepackage55390-37055390-370-10IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201191-001TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDEEQ 4MG BASE/VIALINJECTABLE / INJECTIONAP2011-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A201191-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A201191-001TOPOTECAN HYDROCHLORIDEEQ 4MG BASE/VIALINJECTABLE / INJECTIONAP2011-03-09a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A201191-001AP1a50c72e98297…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55390-370-102024-01-30C16284748780-11030e365-64ad-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use (Topotecan Hydrochloride For Injection) safely and effectively. See full prescribing information for (topotecan hydrochloride for injection). Topotecan Hydrochloride For Injection Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55390-370-10Topotecan Hydrochloride1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
55390-370-10Topotecan Hydrochloride4 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55390-370-10EA - Each55390-37066b73e04-ecab-4afc-9151-ef50fb3b4be812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Topotecan HydrochlorideACTIVE INGREDIENT956S425ZCYTOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ]3
TopotecanACTIVE MOIETY7M7YKX2N15TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ]3
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBTOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ]3
MannitolINACTIVE INGREDIENT3OWL53L36ATOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ]3
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ITOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ]3
Tartaric AcidINACTIVE INGREDIENTW4888I119HTOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55390-370TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BEDFORD LABORATORIES ]5Legacy NDC, 2 package rows20181211_a439bf07-53db-0352-846a-99d9da772f9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1799416topotecan 4 MG InjectionPSNa439bf07-53db-0352-846a-99d9da772f9b5
1799416topotecan 4 MG InjectionSCDa439bf07-53db-0352-846a-99d9da772f9b5
1799416topotecan (as topotecan hydrochloride) 4 MG InjectionSYa439bf07-53db-0352-846a-99d9da772f9b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55390-370-10553900370101 VIAL in 1 CARTON (55390-370-10) > 4 mL in 1 VIAL1 vial2020-12-010000-00-00NoNoCurrent