topotecan hydrochloride

Generic: topotecan hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topotecan hydrochloride
Generic Name topotecan hydrochloride
Labeler actavis pharma, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

topotecan hydrochloride 4 mg/4mL

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 45963-615
Product ID 45963-615_0edbf531-9ae9-4f9d-a606-f8f56768ce9d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090620
Listing Expiration 2026-12-31
Marketing Start 2015-01-05

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45963615
Hyphenated Format 45963-615

Supplemental Identifiers

RxCUI
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 topotecan hydrochloride (source: ndc)
Generic Name topotecan hydrochloride (source: ndc)
Application Number ANDA090620 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/4mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (45963-615-56) / 4 mL in 1 VIAL
source: ndc

Packages (1)

45963-615-56 1 VIAL in 1 CARTON (45963-615-56) / 4 mL in 1 VIAL

Ingredients (1)

topotecan hydrochloride (4 mg/4mL)

Linked Drug Pages (1)

Topotecan hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0edbf531-9ae9-4f9d-a606-f8f56768ce9d", "openfda": {"unii": ["956S425ZCY"], "rxcui": ["1799416"], "spl_set_id": ["996430c0-ee26-4ed9-82b8-a8b645becba6"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (45963-615-56)  / 4 mL in 1 VIAL", "package_ndc": "45963-615-56", "marketing_start_date": "20150105"}], "brand_name": "Topotecan hydrochloride", "product_id": "45963-615_0edbf531-9ae9-4f9d-a606-f8f56768ce9d", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "45963-615", "generic_name": "Topotecan hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topotecan hydrochloride", "active_ingredients": [{"name": "TOPOTECAN HYDROCHLORIDE", "strength": "4 mg/4mL"}], "application_number": "ANDA090620", "marketing_category": "ANDA", "marketing_start_date": "20150105", "listing_expiration_date": "20261231"}