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

Additional Listing Data#

Finished product
Yes
Brand name base
HYCAMTIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOPOTECAN HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii956S425ZCY
Rxcui747193, 747195, 748738, 748740

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cbf6bf79-4ea9-419f-b7df-eefa780730bfProduct name220180125
19c78384-80c8-23c8-a4e6-c197ed91c59eProduct name120140508
302dcbc5-1902-d63c-93ac-bac5e14c2822Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66758-102-11HYCAMTIN10 in 1 BOTTLECAPSULE101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66758-102-11EA - Each66758-1023516268d-e015-4614-98b4-675b253273f612024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66758-102HYCAMTIN (TOPOTECAN) CAPSULE [SANDOZ INC]1Current NDC, 1 package rows20241031_b23b46f5-c276-47f5-8bbd-940680b3f579.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
748738Hycamtin 0.25 MG Oral CapsulePSNb23b46f5-c276-47f5-8bbd-940680b3f5791
748740Hycamtin 1 MG Oral CapsulePSNb23b46f5-c276-47f5-8bbd-940680b3f5791
747195topotecan HCl 0.25 MG Oral CapsulePSNb23b46f5-c276-47f5-8bbd-940680b3f5791
747193topotecan HCl 1 MG Oral CapsulePSNb23b46f5-c276-47f5-8bbd-940680b3f5791
748738topotecan 0.25 MG Oral Capsule [Hycamtin]SBDb23b46f5-c276-47f5-8bbd-940680b3f5791
748740topotecan 1 MG Oral Capsule [Hycamtin]SBDb23b46f5-c276-47f5-8bbd-940680b3f5791
747195topotecan 0.25 MG Oral CapsuleSCDb23b46f5-c276-47f5-8bbd-940680b3f5791
747193topotecan 1 MG Oral CapsuleSCDb23b46f5-c276-47f5-8bbd-940680b3f5791
748738Hycamtin 0.25 MG Oral CapsuleSYb23b46f5-c276-47f5-8bbd-940680b3f5791
748740Hycamtin 1 MG Oral CapsuleSYb23b46f5-c276-47f5-8bbd-940680b3f5791
747195topotecan 250 MCG Oral CapsuleSYb23b46f5-c276-47f5-8bbd-940680b3f5791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66758-102-116675801021110 CAPSULE in 1 BOTTLE (66758-102-11) 10 capsule2024-11-01NoNoCurrent