HYCAMTIN

Product NDC
0078-0673
11-digit product format
000780673
Labeler code
0078
Product ID
0078-0673_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
2017-02-24
Marketing end
0000-00-00
Substance
TOPOTECAN HYDROCHLORIDE
Active strength
1 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
0078-0673-01EA - Each0078-0673a23517c6-d8e5-4224-bd89-02e66c74f0a712017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0673HYCAMTIN (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
0078-0673-010007806730110 CAPSULE in 1 BOTTLE (0078-0673-01) 10 capsule2017-02-240000-00-00NoNoCurrent