ral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if cloudiness or precipitate is observed.
Incompatibilities
The compatibility of Amifostine for injection with solutions other than 0.9% Sodium Chloride for Injection, or Sodium Chloride solutions with other additives, has not been examined. The use of other solutions is not recommended.
How is Amifostine Supplied
Amifostine for Injection USP is supplied as a sterile powder in 10 mL single-use vials (NDC 47335-581-40). Each single-use vial contains 500 mg of Amifostine on the anhydrous basis. The vials are available packaged as follows:
1 pack - 1 vial per carton (NDC 47335-581-40).
3 pack - 3 vials per carton (NDC 47335-581-42).
Store the powder dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].
Distributed by:
Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive, Detroit, MI 48202
Manufactured by:
Sun Pharmaceutical Ind. Ltd.
Halol-Baroda Highway,
Halol-389 350, Gujarat, India.
ISS. 01/2011
PJPI0327
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - vial label
NDC 47335-581-40
Amifostine for Injection USP
500 mg/vial
Sterile
Single use vials
For Intravenous Use
Rx only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - showbox for 1 vial
NDC 47335-581-40
Amifostine for Injection USP
500 mg/vial
Sterile
Single use vials
For Intravenous Use
1 Vial
Rx only
Sun Pharmaceutical Industries Ltd.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - showbox for 3 vials
NDC 47335-581-42
Amifostine for Injection USP
500 mg/vial
Sterile
Single use vials
For Intravenous Use
3 Vials
Rx only
Sun Pharmaceutical Industries Ltd.
Amifostine
Amifostine injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:47335-581
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Amifostine (Amifostine) Amifostine 50 mg in 1 mL
Packaging
# Item Code Package Description
1 NDC:47335-581-40 1 VIAL, SINGLE-USE (VIAL) in 1 CARTON
1 10 mL in 1 VIAL, SINGLE-USE
2 NDC:47335-581-42 3 VIAL, SINGLE-USE (VIAL) in 1 CARTON
2 10 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077126 03/14/2008
Labeler - Sun Pharma Global FZE (864347344)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 manufacture, analysis
Revised: 01/2011
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