hycamtin

Generic: topotecan

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name hycamtin
Generic Name topotecan
Labeler sandoz inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

topotecan hydrochloride .25 mg/1

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 66758-101
Product ID 66758-101_b23b46f5-c276-47f5-8bbd-940680b3f579
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020981
Listing Expiration 2026-12-31
Marketing Start 2017-07-07

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66758101
Hyphenated Format 66758-101

Supplemental Identifiers

RxCUI
747193 747195 748738 748740
UNII
956S425ZCY

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hycamtin (source: ndc)
Generic Name topotecan (source: ndc)
Application Number NDA020981 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .25 mg/1
source: ndc
Packaging
  • 10 CAPSULE in 1 BOTTLE (66758-101-11)
source: ndc

Packages (1)

66758-101-11 10 CAPSULE in 1 BOTTLE (66758-101-11)

Ingredients (1)

topotecan hydrochloride (.25 mg/1)

Linked Drug Pages (1)

HYCAMTIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b23b46f5-c276-47f5-8bbd-940680b3f579", "openfda": {"unii": ["956S425ZCY"], "rxcui": ["747193", "747195", "748738", "748740"], "spl_set_id": ["b23b46f5-c276-47f5-8bbd-940680b3f579"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CAPSULE in 1 BOTTLE (66758-101-11)", "package_ndc": "66758-101-11", "marketing_start_date": "20250106"}], "brand_name": "HYCAMTIN", "product_id": "66758-101_b23b46f5-c276-47f5-8bbd-940680b3f579", "dosage_form": "CAPSULE", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "66758-101", "generic_name": "topotecan", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYCAMTIN", "active_ingredients": [{"name": "TOPOTECAN HYDROCHLORIDE", "strength": ".25 mg/1"}], "application_number": "NDA020981", "marketing_category": "NDA", "marketing_start_date": "20170707", "listing_expiration_date": "20261231"}