Topotecan

Product NDC
0703-4714
11-digit product format
007034714
Labeler code
0703
Product ID
0703-4714_ecf75b05-d006-403c-a5b6-c64c632e6755
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Topotecan
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Teva Parenteral Medicines, Inc.
Application
NDA022453
Marketing category
NDA
Marketing start
2013-05-21
Marketing end
0000-00-00
Substance
TOPOTECAN HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0703-4714-01ML - Milliliter0703-4714c737449c-b2fc-4d32-adac-22f4908d83e412013-06-04
0703-4714-71ML - Milliliter0703-47146d2570f7-0a49-4a5c-abbd-73db6e1ad5f012013-06-04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0703-4714-01007034714011 VIAL, SINGLE-USE in 1 CARTON (0703-4714-01) > 4 mL in 1 VIAL, SINGLE-USE (0703-4714-71) 2013-05-210000-00-00NoNoCurrent