HYCAMTIN

Product NDC
66758-102
11-digit product format
667580102
Labeler code
66758
Product ID
66758-102_b23b46f5-c276-47f5-8bbd-940680b3f579
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
topotecan
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
NDA020981
Marketing category
NDA
Marketing start
2017-02-24
Substance
TOPOTECAN HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
956S425ZCYTOPOTECAN HYDROCHLORIDE119413-54-6TOPOTECAN HYDROCHLORIDE
7M7YKX2N15TOPOTECAN123948-87-8topotecan

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66758-102-116675801021110 CAPSULE in 1 BOTTLE (66758-102-11) 10 capsule2024-11-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
HYCAMTINSandoz Inc2023-09-18HUMAN PRESCRIPTION DRUG LABEL1