Pemetrexed Injection, Powder, Lyophilized, For Solution
Product Images NDC 63323-450

19 FDA label images from Fresenius Kabi Usa, Llc · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Pemetrexed (NDC 63323-450). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Fresenius Kabi Usa, Llc, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Structural Formula (Pem01 0004 01)

Structural Formula (Pem01 0004 01)
Chemical structure of Pemetrexed Disodium, the active ingredient in Pemetrexed injection, lyophilized powder for solution.*
FDA Label Image

Figure 1 (Pem01 0004 02)

Figure 1 (Pem01 0004 02)
A Kaplan-Meier survival curve comparing overall survival (%) over time in months for two treatment arms: P+P+C and P+C. The graph shows a higher survival percentage over time for the P+P+C arm compared to the P+C arm, with numbers at risk indicated below the x-axis for each treatment group at multiple time points.*
FDA Label Image

Figure 2 (Pem01 0004 03)

Figure 2 (Pem01 0004 03)
A survival probability curve comparing treatment outcomes over a 30-month period. The graph displays two lines representing survival rates: one for Pemetrexed plus Cisplatin (PC) and another for Gemcitabine plus Cisplatin (GC), with survival probability on the vertical axis and survival time in months on the horizontal axis. Below the graph, the number of patients at risk for each treatment group is tabulated at various time points.*
FDA Label Image

Figure 3 (Pem01 0004 04)

Figure 3 (Pem01 0004 04)
A Kaplan-Meier survival curve comparing the survival probabilities over 30 months between two treatment groups: Pemetrexed plus Cisplatin (solid line) and Gemcitabine plus Cisplatin (dotted line). The graph includes a table of patient counts at risk over time for each group beneath the x-axis, showing sample sizes decreasing over the duration.*
FDA Label Image

Figure 4 (Pem01 0004 05)

Figure 4 (Pem01 0004 05)
A survival probability plot comparing Pemetrexed + Cisplatin (PC) to Gemcitabine + Cisplatin (GC) over 30 months. The x-axis shows survival time in months, and the y-axis shows survival probability. The chart includes the number of patients at risk at various timepoints for each treatment group.*
FDA Label Image

Figure 5 (Pem01 0004 06)

Figure 5 (Pem01 0004 06)
A Kaplan-Meier survival curve graph showing the survival probability over time in months for patients treated with Pemetrexed versus Placebo. The chart includes two lines representing survival probabilities for each group, with a table underneath listing the number of patients at risk at various time points.*
FDA Label Image

Figure 6 (Pem01 0004 07)

Figure 6 (Pem01 0004 07)
A survival curve graph comparing Pemetrexed versus Placebo over survival time in months. The y-axis shows survival probability from 0.0 to 1.0, and the x-axis shows survival time from 0 to 42 months. The solid line represents Pemetrexed with higher survival probability, and the dotted line represents Placebo. The chart also includes a table of patients at risk for each group at various time points.*
FDA Label Image

Figure 7 (Pem01 0004 08)

Figure 7 (Pem01 0004 08)
A Kaplan-Meier survival curve plotting survival probability against survival time in months. Two groups, Pemetrexed and Placebo, are represented by a solid and a dotted line respectively, showing changes in survival probability over time. The chart includes a table indicating the number of patients at risk at various time points for both groups.*
FDA Label Image

Figure 8 (Pem01 0004 09)

Figure 8 (Pem01 0004 09)
A survival curve chart comparing survival probability over time in months between Pemetrexed and Placebo treatment groups. The vertical axis shows survival probability from 0.1 to 1.0, and the horizontal axis shows survival time up to 36 months. Two lines display declining survival probabilities, with patient counts at risk listed below for each group at various time points.*
FDA Label Image

Figure 9 (Pem01 0004 10)

Figure 9 (Pem01 0004 10)
A Kaplan-Meier survival curve showing survival probability over time in months. It compares two treatment groups: Pemetrexed plus Cisplatin versus Cisplatin alone. The graph includes a table indicating the number of patients at risk at various time points during the study.*
FDA Label Image

Fresenius Kabi Logo (Pem01 0004 11)

FDA Label Image

Package Label- Principal Display – Pemetrexed 100 mg Single-dose Vial Label (Pem01 0004 12)

Package Label- Principal Display – Pemetrexed 100 mg Single-dose Vial Label (Pem01 0004 12)
Pemetrexed for Injection, USP 100 mg per vial single-dose vial label. Contains pemetrexed disodium equivalent to 100 mg pemetrexed, with buffering agents, for intravenous use only. Labeled as a cytotoxic agent. Stores at 20 to 25°C. Labeler: Fresenius Kabi USA, LLC.*
FDA Label Image

Package Label- Principal Display – Pemetrexed 100 mg Single-dose Vial Carton Panel (Pem01 0004 13)

Package Label- Principal Display – Pemetrexed 100 mg Single-dose Vial Carton Panel (Pem01 0004 13)
Packaging label for Pemetrexed injection, USP 100 mg per vial, a single-dose lyophilized powder vial for intravenous use. The label includes dosage details, storage instructions, and a caution that it is a cytotoxic agent. The labeler is Fresenius Kabi USA, LLC, with a barcode and website noted.*
FDA Label Image

Package Label- Principal Display – Pemetrexed 500 mg Single-dose Vial Label (Pem01 0004 14)

Package Label- Principal Display – Pemetrexed 500 mg Single-dose Vial Label (Pem01 0004 14)
Pemetrexed injection, USP 500 mg per vial lyophilized powder for intravenous use. The label states it contains pemetrexed disodium equivalent to 500 mg pemetrexed with mannitol and sodium hydroxide. It is a single-dose vial labeled as a cytotoxic agent, prescription only. Packaged by Fresenius Kabi USA, LLC with storage instructions at 20° to 25°C.*
FDA Label Image

Package Label- Principal Display – Pemetrexed 500 mg Single-dose Vial Carton Panel (Pem01 0004 15)

Package Label- Principal Display – Pemetrexed 500 mg Single-dose Vial Carton Panel (Pem01 0004 15)
Packaging label for Pemetrexed 500 mg per vial injection, lyophilized powder for intravenous use by Fresenius Kabi USA, LLC. The label includes dosage form, strength, reconstitution instructions, storage conditions, and cautions about its cytotoxic nature. It also states that the vial is single-dose and prescription only.*
FDA Label Image

Package Label- Principal Display – Pemetrexed 750 mg Single-dose Vial Label (Pem01 0004 16)

Package Label- Principal Display – Pemetrexed 750 mg Single-dose Vial Label (Pem01 0004 16)
Label for Pemetrexed for Injection, USP 750 mg per vial, a single-dose vial intended for intravenous use. The label indicates it is a cytotoxic agent and Rx only. It includes storage instructions to keep the powder at 20 to 25°C (68 to 77°F) in a USP Controlled Room Temperature environment. The labeler is Fresenius Kabi USA, LLC, Lake Zurich, IL.*
FDA Label Image

Package Label- Principal Display – Pemetrexed 750 mg Single-dose Vial Carton Panel (Pem01 0004 17)

Package Label- Principal Display – Pemetrexed 750 mg Single-dose Vial Carton Panel (Pem01 0004 17)
Packaging label for Pemetrexed injection, USP, 750 mg per vial, powder, lyophilized for solution. The label indicates use for intravenous administration and includes storage instructions, reconstitution directions, and a caution as a cytotoxic agent. The product is labeled by Fresenius Kabi USA, LLC and is a single-dose vial for prescription use only.*
FDA Label Image

Package Label- Principal Display – Pemetrexed 1 Gram Single-dose Vial Label (Pem01 0004 18)

Package Label- Principal Display – Pemetrexed 1 Gram Single-dose Vial Label (Pem01 0004 18)
Pemetrexed for Injection, USP 1 gram per vial powder label for intravenous use, marked as a cytotoxic agent. The single-dose vial label includes storage instructions, ingredients such as pemetrexed disodium and mannitol, and is from Fresenius Kabi USA, LLC, Lake Zurich, IL.*
FDA Label Image

Package Label- Principal Display – Pemetrexed 1 Gram Single-dose Vial Carton Panel (Pem01 0004 19)

Package Label- Principal Display – Pemetrexed 1 Gram Single-dose Vial Carton Panel (Pem01 0004 19)
Packaging label for Pemetrexed for Injection, USP, 1 gram per vial, a lyophilized powder for intravenous injection. The label includes storage instructions, reconstitution details with 0.9% Sodium Chloride Injection, single-dose vial indication, and caution for cytotoxicity. Labeler is Fresenius Kabi USA, LLC, and the label displays the NDC 63323-622-00 with the Fresenius Kabi logo and website.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.