Pemetrexed (Page 9 of 9)

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Pemetrexed for Injection, USP 750 mg/vial — Vial Label

NDC 60505-6068-0

R_X Only

For intravenous use only

Caution: Cytotoxic Agent

Single-Dose Vial

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Pemetrexed for Injection, USP 750 mg/vial — Carton

NDC 60505-6068-0

R_X Only

For intravenous use only

Caution: Cytotoxic Agent

Single-Dose Vial

PEMETREXED pemetrexed disodium injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60505-6068 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEMETREXED DISODIUM (Pemetrexed) Pemetrexed 750 mg in 30 mL

Inactive Ingredients Ingredient Name Strength MANNITOL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60505-6068-0 1 VIAL in 1 CARTON contains a VIAL 1 30 mL in 1 VIAL This package is contained within the CARTON (60505-6068-0)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209851 05/25/2022

Labeler — Apotex Corp (845263701)

Registrant — Apotex Inc (209429182)

Establishment
Name	Address	ID/FEI	Operations
Gland Pharma Limited		650540227	analysis (60505-6068), manufacture (60505-6068)

Revised: 09/2022 Apotex Corp