Pemetrexed (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-4516-01

Pemetrexed Injection
100 mg/4 mL
(25 mg/mL)

Must Dilute Before Intravenous Infusion

Do not mix with calcium-containing infusion solutions.

Store refrigerated

Discard unused portion.

CAUTION: Cytotoxic Agent

Rx Only

4 mLSingle-Dose Vial

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-4514-01

Pemetrexed Injection
500 mg/20 mL
(25 mg/mL)

Must Dilute Before Intravenous Infusion

Do not mix with calcium-containing infusion solutions.

Store refrigerated

Discard unused portion.

CAUTION: Cytotoxic Agent

Rx Only

20 mLSingle-Dose Vial

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0480-4515-01

Pemetrexed Injection
1 g/40 mL
(25 mg/mL)

Must Dilute Before Intravenous Infusion

Do not mix with calcium-containing infusion solutions.

Store refrigerated

Discard unused portion.

CAUTION: Cytotoxic Agent

Rx Only

40 mLSingle-Dose Vial

PEMETREXED pemetrexed solution, concentrate

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-4516 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEMETREXED MONOHYDRATE (PEMETREXED) PEMETREXED MONOHYDRATE 25 mg in 1 mL

Inactive Ingredients Ingredient Name Strength TROMETHAMINE ANHYDROUS CITRIC ACID METHIONINE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0480-4516-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 4 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0480-4516-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208419 06/01/2022

PEMETREXED pemetrexed solution, concentrate

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-4514 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEMETREXED MONOHYDRATE (PEMETREXED) PEMETREXED MONOHYDRATE 25 mg in 1 mL

Inactive Ingredients Ingredient Name Strength TROMETHAMINE ANHYDROUS CITRIC ACID METHIONINE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0480-4514-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0480-4514-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208419 05/31/2022

PEMETREXED pemetrexed solution, concentrate

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0480-4515 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PEMETREXED MONOHYDRATE (PEMETREXED) PEMETREXED MONOHYDRATE 25 mg in 1 mL

Inactive Ingredients Ingredient Name Strength TROMETHAMINE ANHYDROUS CITRIC ACID METHIONINE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0480-4515-01 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE 1 40 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (0480-4515-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208419 05/31/2022

Labeler — Teva Pharmaceuticals, Inc. (022629579)

Revised: 12/2022 Teva Pharmaceuticals, Inc.