Pemetrexed For Injection, For Intravenous Use

SPL v1

SPL

SPL Set ID 6986de29-b077-48ac-ad2b-0cc478f72d89

Route

INTRAVENOUS

Published

Effective Date 2022-05-26

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Pemetrexed (100 mg)

Inactive Ingredients

Mannitol Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status

ANDA Active Since 2022-05-26

Description

NDC 70771-1691-1 Pemetrexed for Injection, USP 100 mg/vial For intravenous use only. Single-Dose Vial Rx only NDC 70771-1691-1 Pemetrexed for Injection, USP 100 mg/vial For intravenous use only. One Single-Dose Vial Carton Rx only NDC 70771-1692-1 Pemetrexed for Injection, USP 500 mg/vial For intravenous use only. Single-Dose Vial Rx only NDC 70771-1692-1 Pemetrexed for Injection, USP 500 mg/vial For intravenous use only. One Single-Dose Vial Carton Rx only NDC 70771-1693-1 Pemetrexed for Injection, USP 1000 mg/vial For intravenous use only. Single-Dose Vial Rx only NDC 70771-1693-1 Pemetrexed for Injection, USP 1000 mg/vial For intravenous use only. One Single-Dose Vial Carton Rx only

Medication Information

Description

Package Label.principal Display Panel

NDC 70771-1691-1

Pemetrexed for Injection, USP

100 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

NDC 70771-1691-1

Pemetrexed for Injection, USP

100 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

NDC 70771-1692-1

Pemetrexed for Injection, USP

500 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

NDC 70771-1692-1

Pemetrexed for Injection, USP

500 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

NDC 70771-1693-1

Pemetrexed for Injection, USP

1000 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

NDC 70771-1693-1

Pemetrexed for Injection, USP

1000 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1691-1

Pemetrexed for Injection, USP

100 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

NDC 70771-1691-1

Pemetrexed for Injection, USP

100 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

NDC 70771-1692-1

Pemetrexed for Injection, USP

500 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

NDC 70771-1692-1

Pemetrexed for Injection, USP

500 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

NDC 70771-1693-1

Pemetrexed for Injection, USP

1000 mg/vial

For intravenous use only.

Single-Dose Vial

Rx only

NDC 70771-1693-1

Pemetrexed for Injection, USP

1000 mg/vial

For intravenous use only.

One Single-Dose Vial Carton

Rx only

Advanced Ingredient Data

[{"name": "PEMETREXED", "unii": "04Q9AIZ7NO", "classCode": "ACTIM", "strengthNumerator": "100", "strengthDenominator": "4", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "106", "strengthDenominator": "4", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEMETREXED", "unii": "04Q9AIZ7NO", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "500", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEMETREXED", "unii": "04Q9AIZ7NO", "classCode": "ACTIM", "strengthNumerator": "1000", "strengthDenominator": "40", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "1000", "strengthDenominator": "40", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1691-1 Pemetrexed for Injection, USP 100 mg/vial For intravenous use only. Single-Dose Vial Rx only NDC 70771-1691-1 Pemetrexed for Injection, USP 100 mg/vial For intravenous use only. One Single-Dose Vial Carton Rx only NDC 70771-1692-1 Pemetrexed for Injection, USP 500 mg/vial For intravenous use only. Single-Dose Vial Rx only NDC 70771-1692-1 Pemetrexed for Injection, USP 500 mg/vial For intravenous use only. One Single-Dose Vial Carton Rx only NDC 70771-1693-1 Pemetrexed for Injection, USP 1000 mg/vial For intravenous use only. Single-Dose Vial Rx only NDC 70771-1693-1 Pemetrexed for Injection, USP 1000 mg/vial For intravenous use only. One Single-Dose Vial Carton Rx only"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:36:56.165726 · Updated: 2026-03-14T21:48:16.255103