NDC Code(s) : 68001-524-28, 68001-524-30, 68001-524-29, 68001-524-31
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:68001-524
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
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68001-524-3010 in 1 CARTON 18/02/2022
1NDC:68001-524-2810 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:68001-524-3110 in 1 CARTON 18/02/2022
2NDC:68001-524-2920 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 ANDA210123 02/18/2022

LABELER - BluePoint Laboratories(985523874)

Establishment
Name Address ID/FEI Business Operations
Gland Pharma Limited 650540227 analysis(68001-524), manufacture(68001-524), pack(68001-524)

PRINCIPAL DISPLAY PANEL

Fluorouracil Injection, USP
NDC 68001-524-28
Container Label-10mL

10mL Vial Label

Fluorouracil Injection, USP
NDC 68001-524-30
Carton Label - 10mL

10mL Vial Label
Fluorouracil Injection, USP
NDC 68001-524-29
Container Label-20mL

10mL Vial Label

Fluorouracil Injection, USP
NDC 68001-524-31
Carton Label - 20mL

10mL Vial Label