topotecan hydrochloride (63323-762)

Drug Facts

Product Profile

Brand Name topotecan hydrochloride

Generic Name topotecan hydrochloride

Labeler fresenius kabi usa, llc

Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Routes

INTRAVENOUS

Active Ingredients

topotecan hydrochloride 4 mg/4mL

Manufacturer

Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-762

Product ID 63323-762_934c9196-bc08-4c9e-9341-37092dbef9dd

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA091089

Listing Expiration 2026-12-31

Marketing Start 2010-11-30

Pharmacologic Class

Classes

topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323762

Hyphenated Format 63323-762

Supplemental Identifiers

RxCUI

1799416

UPC

0363323762940

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 ANDA091089 (source: ndc)

Routes

INTRAVENOUS

source: ndc

Resolved Composition

Strengths

4 mg/4mL

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Topotecan hydrochloride for injection is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder. Topotecan hydrochloride for injection is supplied as follows: Product No. NDC No. Strength PRX760210 63323-762-94 4 mg (free base) per vial Single-dose vial, packaged individually. The container closure is not made with natural rubber latex. 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light; product is light-sensitive. Retain in carton. Handle and dispose of topotecan hydrochloride for injection consistent with recommendations for the handling and disposal of hazardous drugs 1 .
PACKAGE LABEL - PRINCIPAL DISPLAY - Topotecan 4 mg Single Dose Vial Label NDC 63323-762-94 PRX760210 Topotecan Hydrochloride for Injection 4 mg (base) per vial For intravenous use. MUST BE DILUTED Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Topotecan 4 mg Single Dose Vial Label
PACKAGE LABEL - PRINCIPAL DISPLAY - Topotecan 4 mg Single Dose Vial Carton Label NDC 63323-762-94 PRX760210 Topotecan Hydrochloride for Injection 4 mg (base) per vial For intravenous use. MUST BE DILUTED. Cytotoxic agent. Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Topotecan 4 mg Single Dose Vial Carton Label

source: label

Packages (0)

No package records.

Ingredients (1)

topotecan hydrochloride (4 mg/4mL)

Linked Drug Pages (2)

Topotecan Hydrochloride ndc-match (0.9) Topotecan Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["INTRAVENOUS"], "spl_id": "934c9196-bc08-4c9e-9341-37092dbef9dd", "openfda": {"upc": ["0363323762940"], "unii": ["956S425ZCY"], "rxcui": ["1799416"], "spl_set_id": ["b094e6ba-7cf6-4fb8-8683-73d324650dd3"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Topotecan Hydrochloride", "product_id": "63323-762_934c9196-bc08-4c9e-9341-37092dbef9dd", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "63323-762", "generic_name": "TOPOTECAN HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Topotecan Hydrochloride", "active_ingredients": [{"name": "TOPOTECAN HYDROCHLORIDE", "strength": "4 mg/4mL"}], "application_number": "ANDA091089", "marketing_category": "ANDA", "marketing_start_date": "20101130", "listing_expiration_date": "20261231"}