hycamtin

Generic: topotecan hydrochloride

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name hycamtin
Generic Name topotecan hydrochloride
Labeler novartis pharmaceuticals corporation
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

topotecan hydrochloride 4 mg/4mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0674
Product ID 0078-0674_e6e4f66b-e398-44d3-a832-e5a809f3e861
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020671
Listing Expiration 2026-12-31
Marketing Start 2016-12-21

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780674
Hyphenated Format 0078-0674

Supplemental Identifiers

RxCUI
637550 1799416
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 hydrochloride (source: ndc)
Application Number NDA020671 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/4mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61) / 4 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0078-0674-61 1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61) / 4 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

topotecan hydrochloride (4 mg/4mL)

Linked Drug Pages (1)

HYCAMTIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e6e4f66b-e398-44d3-a832-e5a809f3e861", "openfda": {"unii": ["956S425ZCY"], "rxcui": ["637550", "1799416"], "spl_set_id": ["eeee060c-a9ec-423e-a374-8484009f8524"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61)  / 4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0078-0674-61", "marketing_start_date": "20161221"}], "brand_name": "HYCAMTIN", "product_id": "0078-0674_e6e4f66b-e398-44d3-a832-e5a809f3e861", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0078-0674", "generic_name": "topotecan hydrochloride", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYCAMTIN", "active_ingredients": [{"name": "TOPOTECAN HYDROCHLORIDE", "strength": "4 mg/4mL"}], "application_number": "NDA020671", "marketing_category": "NDA", "marketing_start_date": "20161221", "listing_expiration_date": "20261231"}