HYCAMTIN- topotecan hydrochloride injection, powder, lyophilized, for solution 
GlaxoSmithKline Manufacturing SpA

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PRINCIPAL DISPLAY PANEL

NDC 0007-4201-01

HYCAMTIN®

TOPOTECAN HYDROCHLORIDE

FOR INJECTION

4 mg

For Intravenous Use

Rx only

Store at controlled room temperature between 20o and 25oC (68o and 77oF) [see USP]. Protect from light; product is light-sensitive.

Dosage: See accompanying prescribing information. Hycamtin is cytotoxic. Safe handling: Use caution in handling. See prescribing information for additional precautions. If solution contacts the skin, wash thoroughly with soap and water. Flush mucous membranes thoroughly with water.

GlaxoSmithKline

Research Triangle Park, NC 27709

10000000023714

HYCAMTIN Injection Label Image - 4mg
HYCAMTIN 
topotecan hydrochloride injection, powder, lyophilized, for solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:12064-002
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOPOTECAN HYDROCHLORIDE (UNII: 956S425ZCY) (TOPOTECAN - UNII:7M7YKX2N15) TOPOTECAN4 mg  in 4 mL
Inactive Ingredients
Ingredient NameStrength
MANNITOL (UNII: 3OWL53L36A)  
TARTARIC ACID (UNII: W4888I119H)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorYELLOW (yellow to greenish) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12064-002-001 in 1 PACKAGE06/07/1996
14 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA02067106/07/1996
Labeler - GlaxoSmithKline Manufacturing SpA (338471078)

Revised: 11/2017
Document Id: 6eaebc7d-d54e-41b1-892d-b3b843696194
Set id: c46a2a4e-90f5-44e7-9973-c1a580be0106
Version: 2
Effective Time: 20171114
 
GlaxoSmithKline Manufacturing SpA