NDC Code(s) : 68001-266-28, 68001-266-30, 68001-266-29, 68001-266-31
Packager : BluePoint Laboratories

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FluorouracilFluorouracil INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68001-266
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOROURACIL(UNII: U3P01618RT)
(FLUOROURACIL - UNII:U3P01618RT) 		FLUOROURACIL50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-266-3010 in 1 CARTON 15/12/2014
1NDC:68001-266-2810 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:68001-266-3110 in 1 CARTON 15/12/2014
2NDC:68001-266-2920 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 ANDA040743 12/15/2014

LABELER - BluePoint Laboratories(985523874)

Establishment
Name Address ID/FEI Business Operations
Intas Pharmaceuticals Ltd 725927649 MANUFACTURE(68001-266), ANALYSIS(68001-266)

Establishment
Name Address ID/FEI Business Operations
Intas Pharmaceuticals Ltd 915837971 MANUFACTURE(68001-266), ANALYSIS(68001-266)

PRINCIPAL DISPLAY PANEL

Fluorouracil Injection, USP

500 mg/10 mL (50 mg/mL) Vial Label

NDC 68001-266-28

Fluorouracil 50mgml 10ml Rev1114

PRINCIPAL DISPLAY PANEL

Fluorouracil Injection, USP

500 mg/10 mL (50 mg/mL) Vial Label

NDC 68001-266-28

Fluorouracil 50mgml 10ml Rev09-16 - Single-Dose

PRINCIPAL DISPLAY PANEL

Fluorouracil Injection, USP

500 mg/10 mL (50 mg/mL) Carton Label

NDC 68001-266-30

Fluorouracil 500mg 10ml carton Rev1114

PRINCIPAL DISPLAY PANEL

Fluorouracil Injection, USP

500 mg/10 mL (50 mg/mL) Carton Label

NDC 68001-266-30

Fluorouracil 500mg 10ml carton Rev09-16 - Single-Dose

PRINCIPAL DISPLAY PANEL

Fluorouracil Injection, USP

1 g/20 mL (50 mg/mL) Vial Label

NDC 68001-266-29

Fluorouracil 50mgml 20ml Rev1114

PRINCIPAL DISPLAY PANEL

Fluorouracil Injection, USP

1 g/20 mL (50 mg/mL) Vial Label

NDC 68001-266-29

Fluorouracil 50mgml 20ml Rev09-16 - Single-Dose

PRINCIPAL DISPLAY PANEL

Fluorouracil Injection, USP

1 g/20 mL (50 mg/mL) Carton Label

NDC 68001-266-31

Fluorouracil 1g 20ml carton Rev1114

PRINCIPAL DISPLAY PANEL

Fluorouracil Injection, USP

1 g/20 mL (50 mg/mL) Carton Label

NDC 68001-266-31

Fluorouracil 1g 20ml carton Rev09-16 - Single-Dose