HYCAMTIN

Product NDC
0078-0672
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

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