Prescription Drug Information: PEMETREXED (Page 6 of 6)

PRINCIPAL DISPLAY PANEL — 4 mL Vial Label

Rx only
NDC 0409-1045-01

Single Dose Vial — Discard Unused Portion
Sterile

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

For Intravenous Infusion After DilutionWarning: Hazardous Drug

Store refrigerated at 2°C to 8°C (36°F to 46°F).

PRINCIPAL DISPLAY PANEL -- 4 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 4 mL Vial Carton

1 x 4 mL vial
NDC 0409-1045-01

Sterile
Rx only

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

For Intravenous
Infusion After Dilution

Single Dose Vial Discard Unused Portion

Hospira

Warning: Hazardous Drug

PRINCIPAL DISPLAY PANEL -- 4 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mL Vial Label

Rx only
NDC 0409-2188-01

Single Dose Vial — Discard Unused Portion
Sterile

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

For Intravenous Infusion After Dilution

Store refrigerated at 2°C to 8°C (36°F to 46°F).

Warning: Hazardous Drug

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

PRINCIPAL DISPLAY PANEL — 20 mL Vial Carton

1 x 20 mL vial
NDC 0409-2188-01

Sterile
Rx only

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

For Intravenous
Infusion After Dilution

Single Dose Vial Discard Unused Portion

Hospira

Warning: Hazardous Drug

PRINCIPAL DISPLAY PANEL -- 20 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mL Vial Label

Rx only
NDC 0409-3532-01

Single Dose Vial — Discard Unused Portion
Sterile

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

For Intravenous Infusion After Dilution

Store refrigerated at 2°C to 8°C (36°F to 46°F).

Hospira

Warning: Hazardous Drug

PRINCIPAL DISPLAY PANEL -- 40 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mL Vial Carton

1 x 40 mL vial
NDC 0409-3532-01

Sterile
Rx only

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

For Intravenous
Infusion After Dilution

Single Dose Vial Discard Unused Portion

Hospira

Warning: Hazardous Drug

PRINCIPAL DISPLAY PANEL -- 40 mL Vial Carton
(click image for full-size original)
PEMETREXED pemetrexed injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-1045
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEMETREXED DISODIUM (PEMETREXED) PEMETREXED 100 mg in 4 mL
Inactive Ingredients
Ingredient Name Strength
MONOTHIOGLYCEROL
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-1045-01 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 (0409-1045-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214218 06/27/2022
PEMETREXED pemetrexed injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-2188
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEMETREXED DISODIUM (PEMETREXED) PEMETREXED 500 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
MONOTHIOGLYCEROL
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-2188-01 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 (0409-2188-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214218 06/27/2022
PEMETREXED pemetrexed injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-3532
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEMETREXED DISODIUM (PEMETREXED) PEMETREXED 1 g in 40 mL
Inactive Ingredients
Ingredient Name Strength
MONOTHIOGLYCEROL
WATER
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-3532-01 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 (0409-3532-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214218 06/27/2022
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Zydus Hospira Oncology Private Limited 676190889 ANALYSIS (0409-1045), ANALYSIS (0409-2188), ANALYSIS (0409-3532), MANUFACTURE (0409-1045), MANUFACTURE (0409-2188), MANUFACTURE (0409-3532), PACK (0409-1045), PACK (0409-2188), PACK (0409-3532), LABEL (0409-1045), LABEL (0409-2188), LABEL (0409-3532)

Revised: 07/2022 Hospira, Inc.

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