NDC Code(s) : 63323-172-60
Packager : Fresenius Kabi USA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Carboplatin CARBOPLATIN INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-172
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBOPLATIN(UNII: BG3F62OND5)
(CARBOPLATIN - UNII:BG3F62OND5) 		CARBOPLATIN10 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-172-601 in 1 BOX 12/11/2009
160 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077266 12/11/2009

LABELER - Fresenius Kabi USA, LLC(608775388)

Establishment
Name Address ID/FEI Business Operations
Fresenius Kabi USA, LLC 023648251 analysis(63323-172), manufacture(63323-172)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY -  Carboplatin 600 mg per 60 mL Multiple Dose Vial Label


NDC 63323-172-60 107260

CARBOplatin Injection

600 mg per 60 mL
(10 mg per mL)

For intravenous use.
Preservative free.
Cytotoxic agent.

60 mL

Multiple Dose Vial Rx only


vial

PACKAGE LABEL - PRINCIPAL DISPLAY -  Carboplatin 600 mg per 60 mL Multiple Dose Vial Carton Panel 


NDC 63323-172-60 107260

CARBOplatin Injection

600 mg per 60 mL
(10 mg per mL)

For intravenous use.
Preservative free.
Cytotoxic agent.
Rx only
60 mL

Multiple Dose Vial

  vial