FDA.reportPublic FDA data

HYCAMTIN

Product NDC
0078-0672
Requested package NDC
0078-0672-01
11-digit product format
000780672
Labeler code
0078
Product ID
0078-0672_bf2754e4-bfee-452c-a095-3038c45d56c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topotecan
Dosage form
CAPSULE
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA020981
Marketing category
NDA
Marketing start
2017-07-07
Marketing end
0000-00-00
Substance
TOPOTECAN HYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0078-06720078-0672-01DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020981-001HYCAMTINTOPOTECAN HYDROCHLORIDEEQ 0.25MG BASECAPSULE / ORALRLD2007-10-11
N020981-002HYCAMTINTOPOTECAN HYDROCHLORIDEEQ 1MG BASECAPSULE / ORALRLD, RS2007-10-11

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 22:54:322026-06N020981-001HYCAMTINEQ 0.25MG BASECAPSULE / ORALRLD2007-10-11a50c72e98297…
2026-08-01 22:54:322026-06N020981-002HYCAMTINEQ 1MG BASECAPSULE / ORALRLD, RS2007-10-11a50c72e98297…

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
HYCAMTINTOPOTECANSandoz Incb23b46f5-c276-47f5-8bbd-940680b3f5792023-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020981
application number: NDA020981

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0672-01EA - Each0078-0672a0740c4d-dcba-4974-a1b6-d1d5128b8a7112017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0672HYCAMTIN (TOPOTECAN) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION]8Legacy NDC20220709_aa0815bb-8916-4c2c-9201-b04eb78e91fa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0672-010007806720110 CAPSULE in 1 BOTTLE (0078-0672-01) 10 capsule2017-07-070000-00-00NoNoCurrent