FDA.reportPublic FDA data

Topotecan Hydrochloride

Product NDC
63323-762
11-digit product format
633230762
Labeler code
63323
Product ID
63323-762_7f91362f-6b55-4518-b034-b54aa5881204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOPOTECAN HYDROCHLORIDE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA091089
Marketing category
ANDA
Marketing start
2010-11-30
Substance
TOPOTECAN HYDROCHLORIDE
Active strength
4 mg/4mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63323-762DDiscontinued by firm2026-07-31
excluded productproduct63323-762DDiscontinued by firm2026-07-31
excluded packagepackage63323-76263323-762-94DDiscontinued by firm2026-07-31
excluded packagepackage63323-76263323-762-55DDiscontinued by firm2026-07-31
excluded packagepackage63323-76263323-762-57DDiscontinued by firm2026-07-31

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
A091089-001TOPOTECAN HYDROCHLORIDETOPOTECAN HYDROCHLORIDEEQ 4MG BASE/VIALINJECTABLE / INJECTIONAP2010-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091089-001AP

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 22:54:322026-06A091089-001TOPOTECAN HYDROCHLORIDEEQ 4MG BASE/VIALINJECTABLE / INJECTIONAP2010-11-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091089-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topotecan HydrochlorideTOPOTECAN HYDROCHLORIDEFresenius Kabi USA, LLCb6019088-cd94-43b4-b5ce-ba20b6b8021e2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091089
application number: ANDA091089
ndc (product): 63323-762

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPOTECAN HYDROCHLORIDE4 mg/4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
956S425ZCYInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1799416Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6019088-cd94-43b4-b5ce-ba20b6b8021eAvailable on FDA.report

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
63323-762-10Topotecan Hydrochloride1 in 1 BOXINJECTION, POWDER, LYOPHILIZED,115
63323-762-10Topotecan Hydrochloride4 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-762-10EA - Each63323-7621018eb56-e99d-4b4f-b87f-c915aecdf76b12013-02-13
63323-762-17EA - Each63323-762723c6eb3-565a-46be-9f37-694c0d613cdc12013-02-13
63323-762-94EA - Each63323-762a90264b3-9d81-424e-90c6-05d7165e258312013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOPOTECAN HYDROCHLORIDEACTIVE INGREDIENT956S425ZCYTOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
TOPOTECANACTIVE MOIETY7M7YKX2N15TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBTOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ATOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ITOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HTOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-762TOPOTECAN HYDROCHLORIDE (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]14Current NDC, Legacy NDC, 2 package rows20240724_b6019088-cd94-43b4-b5ce-ba20b6b8021e.zip
63323-762TOPOTECAN HYDROCHLORIDE (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]4Current NDC, Legacy NDC20210626_b094e6ba-7cf6-4fb8-8683-73d324650dd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1799416topotecan 4 MG InjectionPSNb6019088-cd94-43b4-b5ce-ba20b6b8021e15
1799416topotecan 4 MG InjectionSCDb6019088-cd94-43b4-b5ce-ba20b6b8021e15
1799416topotecan (as topotecan hydrochloride) 4 MG InjectionSYb6019088-cd94-43b4-b5ce-ba20b6b8021e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-762-10633230762101 VIAL in 1 BOX (63323-762-10) / 4 mL in 1 VIAL1 vial2010-11-300000-00-00NoNoCurrent
63323-762-94633230762941 VIAL in 1 BOX (63323-762-94) > 4 mL in 1 VIAL1 vial2010-11-300000-00-00NoNoCurrent