Pemetrexed (Page 6 of 6)

VIAL LABEL– Pemetrexed for Injection 100 mg single-dose vial

NDC 50742-340 -01

Pemetrexed for Injection, USP

100 mg/Vial

For intravenous use only

Single-Dose Vial

Caution: Cytotoxic Agent

Rx Only

VIAL LABEL– Pemetrexed for Injection 100 mg single-dose vial
(click image for full-size original)

PACKAGE CARTON – Pemetrexed for Injection 100 mg single-dose vial

NDC 50742-340 -01

Pemetrexed for Injection, USP

100 mg/Vial

For intravenous use only

Single-Dose Vial

Discard Unused Portion

Caution: Cytotoxic Agent

Rx Only

PACKAGE CARTON – Pemetrexed for Injection 100 mg single-dose vial
(click image for full-size original)

VIAL LABEL– Pemetrexed for Injection 500 mg single-dose vial

NDC 50742-341 -01

Pemetrexed for Injection, USP

500 mg/Vial

For intravenous use only

Single-Dose Vial

Caution: Cytotoxic Agent

Rx Only

VIAL LABEL– Pemetrexed for Injection 500 mg single-dose vial
(click image for full-size original)

PACKAGE CARTON – Pemetrexed for Injection 500 mg single-dose vial

NDC 50742-341 -01

Pemetrexed for Injection, USP

500 mg/Vial

For intravenous use only

Single-Dose Vial

Discard Unused Portion

Caution: Cytotoxic Agent

Rx Only

PACKAGE CARTON – Pemetrexed for Injection 500 mg single-dose vial
(click image for full-size original)

PEMETREXED pemetrexed disodium injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-340
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEMETREXED DISODIUM HEMIPENTAHYDRATE (PEMETREXED) PEMETREXED 100 mg in 4 mL
Inactive Ingredients
Ingredient Name Strength
Mannitol 106 mg in 4 mL
Hydrochloric acid
Sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50742-340-01 1 VIAL in 1 CARTON contains a VIAL
1 4 mL in 1 VIAL This package is contained within the CARTON (50742-340-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204890 05/24/2022
PEMETREXED pemetrexed disodium injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-341
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PEMETREXED DISODIUM HEMIPENTAHYDRATE (Pemetrexed) Pemetrexed 500 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
Mannitol 500 mg in 20 mL
Hydrochloric acid
Sodium hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50742-341-01 1 VIAL in 1 CARTON contains a VIAL
1 20 mL in 1 VIAL This package is contained within the CARTON (50742-341-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204890 05/24/2022
Labeler — Ingenus Pharmaceuticals, LLC (833250017)
Establishment
Name Address ID/FEI Operations
Qilu Pharmaceutical (Hainan) Co., Ltd. 529131725 manufacture (50742-340), analysis (50742-340), label (50742-340), pack (50742-340), manufacture (50742-341), analysis (50742-341), label (50742-341), pack (50742-341)

Revised: 12/2023 Ingenus Pharmaceuticals, LLC

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