TOPOTECAN HYDROCHLORIDE

Product NDC
69097-262
11-digit product format
690970262
Labeler code
69097
Product ID
69097-262_4e757b90-6761-4586-914f-6bc194402399
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOPOTECAN HYDROCHLORIDE
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Cipla USA Inc.
Application
ANDA091199
Marketing category
ANDA
Marketing start
2010-12-01
Marketing end
0000-00-00
Substance
TOPOTECAN HYDROCHLORIDE
Active strength
4 mg/4mL
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-262-67690970262671 VIAL, SINGLE-DOSE in 1 CARTON (69097-262-67) > 4 mL in 1 VIAL, SINGLE-DOSE2010-12-010000-00-00NoNoCurrent
69097-262-68690970262685 VIAL, SINGLE-DOSE in 1 CARTON (69097-262-68) > 4 mL in 1 VIAL, SINGLE-DOSE2010-12-010000-00-00NoNoCurrent