topotecan

Generic: topotecan

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name topotecan
Generic Name topotecan
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVENOUS
Active Ingredients

topotecan hydrochloride 1 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-0302
Product ID 0409-0302_293334d4-88f2-4ec2-9eed-20975ff65c0a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA200582
Listing Expiration 2026-12-31
Marketing Start 2011-02-21

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04090302
Hyphenated Format 0409-0302

Supplemental Identifiers

RxCUI
1799424
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 topotecan (source: ndc)
Generic Name topotecan (source: ndc)
Application Number NDA200582 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0302-01) / 4 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0409-0302-01 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0302-01) / 4 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

topotecan hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Topotecan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "293334d4-88f2-4ec2-9eed-20975ff65c0a", "openfda": {"unii": ["956S425ZCY"], "rxcui": ["1799424"], "spl_set_id": ["1d4e1cce-c57e-4a8b-be96-f95a2778e221"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0409-0302-01)  / 4 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0409-0302-01", "marketing_start_date": "20110221"}], "brand_name": "Topotecan", "product_id": "0409-0302_293334d4-88f2-4ec2-9eed-20975ff65c0a", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0409-0302", "generic_name": "TOPOTECAN", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topotecan", "active_ingredients": [{"name": "TOPOTECAN HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "NDA200582", "marketing_category": "NDA", "marketing_start_date": "20110221", "listing_expiration_date": "20261231"}