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PACKAGE CARTON - FOLOTYN 20 mg/1 mL Vial
NDC 48818-001-01
FOLOTYN™
(pralatrexate injection)
20 mg/mL
For intravenous use
Rx only
1 mL
PACKAGE CARTON - FOLOTYN 40 mg/2 mL Vial
NDC 48818-001-02
FOLOTYN™
(pralatrexate injection)
40 mg/2 mL
(20 mg/mL)
For intravenous use
Rx only
2 mL
VIAL – FOLOTYN 20 mg/1 ml
NDC 48818-001-01
FOLOTYN™
(pralatrexate injection)
20 mg/mL
Rx only
1 mL
VIAL – FOLOTYN 40 mg/2 ml
NDC 48818-001-02
FOLOTYN™
(pralatrexate injection)
40 mg/2 mL
(20 mg/mL)
Rx only
2 mL
FOLOTYN
pralatrexate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:48818-001
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
pralatrexate (pralatrexate) pralatrexate 20mg in1mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride
sodium hydroxide
hydrochloric acid
water
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:48818-001-01 1 VIAL, SINGLE-USE (1 VIAL) in 1 CARTON contains a VIAL, SINGLE-USE
1 1 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON(48818-001-01)
2 NDC:48818-001-02 1 VIAL, SINGLE-USE (1 VIAL) in 1 CARTON contains a VIAL, SINGLE-USE
2 2 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON(48818-001-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022468 09/24/2009
Labeler -Allos Therapeutics (835393869)
