Fluorouracil (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — Fluorouracil Injection, USP NDC 70700-186-22 Container Label-10mL

Fluorouracil Injection, USP
NDC 70700-186-22Container Label-10mL

PRINCIPAL DISPLAY PANEL -- 10 mL Container Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Fluorouracil Injection, USP NDC 70700-186-23 Carton-10mL

Fluorouracil Injection, USP NDC 70700-186-23Carton Label — 10mL

PRINCIPAL DISPLAY PANEL -- 10 mL Carton Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Fluorouracil Injection, USP NDC 70700-187-22 Container Label-20mL

Fluorouracil Injection, USP
NDC 70700-187-22Container Label-20mL

PRINCIPAL DISPLAY PANEL -- 20 mL Container Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — Fluorouracil Injection, USP NDC 70700-187-23 Carton-20mL

Fluorouracil Injection, USP NDC 70700-187-23Carton Label — 20mL

PRINCIPAL DISPLAY PANEL -- 20 mL Carton Label
(click image for full-size original)
FLUOROURACIL fluorouracil injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-186
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOROURACIL (FLUOROURACIL) FLUOROURACIL 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-186-23 10 VIAL in 1 CARTON contains a VIAL (70700-186-22)
1 NDC:70700-186-22 10 mL in 1 VIAL This package is contained within the CARTON (70700-186-23)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210123 08/13/2021
FLUOROURACIL fluorouracil injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70700-187
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOROURACIL (FLUOROURACIL) FLUOROURACIL 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70700-187-23 10 VIAL in 1 CARTON contains a VIAL (70700-187-22)
1 NDC:70700-187-22 20 mL in 1 VIAL This package is contained within the CARTON (70700-187-23)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210123 08/13/2021
Labeler — Xiromed LLC (080228637)
Establishment
Name Address ID/FEI Operations
Gland Pharma Limited 650540227 analysis (70700-186), analysis (70700-187), manufacture (70700-186), manufacture (70700-187), pack (70700-186), pack (70700-187)

Revised: 02/2022 Xiromed LLC

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