NDC Code(s) : 40028-511-30, 40028-511-50
Packager : PETNET Solutions, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Fludeoxyglucose F 18Fludeoxyglucose F 18 INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40028-511
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUDEOXYGLUCOSE F-18(UNII: 0Z5B2CJX4D)
(FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D) 		FLUDEOXYGLUCOSE F-18200 mCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)4.5 mg in 1 mL
ALCOHOL(UNII: 3K9958V90M)5 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:40028-511-301 in 1 CAN 29/07/2008
130 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
2NDC:40028-511-501 in 1 CAN 29/07/2008
250 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079086 07/29/2008

LABELER - PETNET Solutions, Inc.(015223951)

PRINCIPAL DISPLAY PANEL

VIAL LABELS

PRINCIPAL DISPLAY PANEL
Fludeoxyglucose F 18 Injection, USP
20-200 mCi/mL at End of Synthesis (EOS)
Diagnostic-For Intravenous Use Only
Sterile, Non-pyrogenic       Expires 12 hours after EOS 
NDC# 40028-511-30
30 mL Multiple-Dose Vial
CAUTION: RADIOACTIVE MATERIAL

RX ONLY
Manufactured by PETNET Solutions, Inc, Knoxville, TN 37932

PRINCIPAL DISPLAY PANEL Fludeoxyglucose F 18 Injection, USP 20-200 mCi/mL at End of Synthesis (EOS) Diagnostic-For Intravenous Use Only Sterile, Non-pyrogenic Expires 12 hours after EOS NDC# 40028-511-30 30 mL Multiple-Dose Vial CAUTION: RADIOACTIVE MATERIAL RX ONLY Manufactured by PETNET Solutions, Inc, Knoxville, TN 37932

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
Fludeoxyglucose F 18 Injection, USP
20-200 mCi/mL at End of Synthesis (EOS)
Diagnostic-For Intravenous Use Only
Sterile, Non-pyrogenic       Expires 12 hours after EOS 
NDC# 40028-511-50
50 mL Multiple-Dose Vial
CAUTION: RADIOACTIVE MATERIAL

RX ONLY
Manufactured by PETNET Solutions, Inc, Knoxville, TN 37932

PRINCIPAL DISPLAY PANEL Fludeoxyglucose F 18 Injection, USP 20-200 mCi/mL at End of Synthesis (EOS) Diagnostic-For Intravenous Use Only Sterile, Non-pyrogenic Expires 12 hours after EOS NDC# 40028-511-50 50 mL Multiple-Dose Vial CAUTION: RADIOACTIVE MATERIAL RX ONLY Manufactured by PETNET Solutions, Inc, Knoxville, TN 37932