Pemetrexed (Page 6 of 6)

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

1
(click image for full-size original)

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

1
(click image for full-size original)

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

1
(click image for full-size original)
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: 10/2021 Teva Pharmaceuticals, Inc.

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