FDA.reportPublic FDA data

HYCAMTIN

Product NDC
0078-0674
Requested package NDC
0078-0674-61
11-digit product format
000780674
Labeler code
0078
Product ID
0078-0674_e6e4f66b-e398-44d3-a832-e5a809f3e861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topotecan hydrochloride
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA020671
Marketing category
NDA
Marketing start
2016-12-21
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

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
N020671-001HYCAMTINTOPOTECAN HYDROCHLORIDEEQ 4MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1996-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020671-001AP

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 22:54:322026-06N020671-001HYCAMTINEQ 4MG BASE/VIALINJECTABLE / INJECTIONAPRLD, RS1996-05-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020671-001AP1a50c72e98297…

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
HYCAMTINTOPOTECAN HYDROCHLORIDENovartis Pharmaceuticals Corporationeeee060c-a9ec-423e-a374-8484009f85242022-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020671
application number: NDA020671
ndc (package): 0078-0674-61
ndc (product): 0078-0674
ndc11 (package): 00078067461

Additional Listing Data#

Finished product
Yes
Brand name base
HYCAMTIN
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637550Internal RxNorm lookup
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
eeee060c-a9ec-423e-a374-8484009f8524Available 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
0078-0674-61HYCAMTIN4 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,48
0078-0674-61HYCAMTIN1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0674-61EA - Each0078-06741eb32658-3f13-4dd5-905c-5f814a47298712017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0674HYCAMTIN (TOPOTECAN HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]8Current NDC, Legacy NDC, 2 package rows20220709_eeee060c-a9ec-423e-a374-8484009f8524.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637550HYCAMTIN 4 MG InjectionPSNeeee060c-a9ec-423e-a374-8484009f85248
1799416topotecan 4 MG InjectionPSNeeee060c-a9ec-423e-a374-8484009f85248
637550topotecan 4 MG Injection [Hycamtin]SBDeeee060c-a9ec-423e-a374-8484009f85248
1799416topotecan 4 MG InjectionSCDeeee060c-a9ec-423e-a374-8484009f85248
637550Hycamtin 4 MG InjectionSYeeee060c-a9ec-423e-a374-8484009f85248
1799416topotecan (as topotecan hydrochloride) 4 MG InjectionSYeeee060c-a9ec-423e-a374-8484009f85248

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0078-0674-61000780674611 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61) / 4 mL in 1 VIAL, SINGLE-DOSE2016-12-210000-00-00NoNoCurrent