NDC Code(s) : 0069-0076-01, 0069-0078-01, 0069-0079-01
Packager : Pfizer Laboratories Div Pfizer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

paclitaxelpaclitaxel INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0076
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PACLITAXEL(UNII: P88XT4IS4D)
(PACLITAXEL - UNII:P88XT4IS4D) 		PACLITAXEL100 mg in 16.7 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
ALCOHOL(UNII: 3K9958V90M)
Product Characteristics
Color YELLOW (colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-0076-0116.7 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091540 09/30/2011

INGREDIENTS AND APPEARANCE

paclitaxelpaclitaxel INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0078
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PACLITAXEL(UNII: P88XT4IS4D)
(PACLITAXEL - UNII:P88XT4IS4D) 		PACLITAXEL300 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
ALCOHOL(UNII: 3K9958V90M)
Product Characteristics
Color YELLOW (Colorless to slighlty yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-0078-0150 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091540 09/30/2011

INGREDIENTS AND APPEARANCE

paclitaxelpaclitaxel INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0069-0079
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PACLITAXEL(UNII: P88XT4IS4D)
(PACLITAXEL - UNII:P88XT4IS4D) 		PACLITAXEL30 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
ALCOHOL(UNII: 3K9958V90M)
Product Characteristics
Color YELLOW (colorless to slightly yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0069-0079-015 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091540 09/30/2011

PRINCIPAL DISPLAY PANEL

vial label-5mLvial label-5mL vial label-5mLvial label-16.7mL vial label-5mLvial label-50mL