Mesna

MESNA- mesna injection, solution
Hikma Farmaceutica

ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling.

• Hypersensitivity Reactions [see Warnings and Precautions (5.1)]

• Dermatological Toxicity [see Warnings and Precautions (5.2)]

• Benzyl Alcohol Toxicity[see Warnings and Precautions (5.3)]

• Laboratory Test Interferences [see Warnings and Precautions (5.4)]

• Use in Patients with a History of Adverse Reactions to Thiol Compounds [see Warnings and Precautions (5.5)]

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0143-9260-01

Rx only

Mesna Injection

1 g/10 mL

(100 mg/mL)

FOR INTRAVENOUS USE

10 mL Mutliple-Dose Vial

NDC 0143-9260-01

Rx only

Mesna Injection

1 g/10 mL

(100 mg/mL)

FOR INTRAVENOUS USE

10 mL Mutliple-Dose Vial carton

MESNA mesna injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62778-304 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MESNA (2-MERCAPTOETHANESULFONIC ACID) MESNA 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM 0.25 mg in 1 mL BENZYL ALCOHOL 10.4 mg in 1 mL SODIUM HYDROXIDE HYDROCHLORIC ACID

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:62778-304-01 1 VIAL in 1 CARTON contains a VIAL 1 10 mL in 1 VIAL This package is contained within the CARTON (62778-304-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075739 02/23/2004

Labeler — Hikma Farmaceutica (452742943)

Registrant — Hikma Pharmaceuticals USA Inc. (001230762)

Revised: 05/2023 Hikma Farmaceutica