Gemcitabine Injection, Solution
Product Images NDC 71288-117

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 71288-117). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Meitheal Pharmaceuticals Inc., 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 (Gem0g 0004 01)

Chemical structure of Gemcitabine hydrochloride, showing the molecular arrangement including a pyrimidine ring with NH2 and HCl components, a fluorinated sugar moiety, and hydroxyl groups.*

FDA Label Image

Figure 1 (Gem0g 0004 02)

A Kaplan-Meier survival curve chart showing progression-free survival probability over time (months). Two treatment groups are compared: Gemcitabine/Carboplatin (N=178) and Carboplatin alone (N=178). The chart includes median progression-free survival values and a log-rank p-value comparing the groups.*

FDA Label Image

Figure 2 (Gem0g 0004 03)

A Kaplan-Meier curve graph showing time to documented disease progression in months for two treatment groups: Gemcitabine/Paclitaxel (N=267) and Paclitaxel alone (N=262). The y-axis represents progression-free probability, and the x-axis represents time in months up to 24. Median times to progression are 5.2 months for Gemcitabine/Paclitaxel and 2.9 months for Paclitaxel. The log rank p-value is less than 0.0001.*

FDA Label Image

Figure 3 (Gem0g 0004 04)

A Kaplan-Meier survival curve chart comparing survival probability over time (months) between two patient groups receiving Cisplatin alone and Gemcitabine/Cisplatin combination therapy. The graph shows median survival and 1-year survival rates, with statistical test results (Logrank and Wilcoxon) and associated p-values indicating significance.*

FDA Label Image

Figure 4 (Gem0g 0004 05)

A survival curve graph comparing the fraction surviving over time in months between Gemcitabine and 5-FU treatments. The x-axis represents survival time in months, and the y-axis represents the fraction surviving, illustrating differences in survival outcomes between the two treatments.*

FDA Label Image

Principal Display Panel – Gemcitabine Injection 200 mg Vial Label (Gem0g 0004 Viz 06)

Gemcitabine injection, solution with a strength of 38 mg/mL, packaged as 200 mg per 5.26 mL vial. The label includes instructions for intravenous infusion only and a warning that the product must be diluted before use due to cytotoxicity. It is labeled as prescription only and manufactured by Meitheal Pharmaceuticals Inc.*

FDA Label Image

Principal Display Panel – Gemcitabine Injection 200 mg Carton (Gem0g 0004 Viz 07)

Packaging label for Gemcitabine Injection 200 mg per 5.26 mL (38 mg per mL), an intravenous infusion solution by Meitheal Pharmaceuticals Inc. The label includes dosage form, strength, caution that it must be diluted before use, storage instructions between 2° and 8°C, single-dose vial information, and a warning that the product is cytotoxic. The label also shows the NDC number 71288-117-91 and barcode with manufacturer details.*

FDA Label Image

Principal Display Panel – Gemcitabine Injection 1 Gram Vial Label (Gem0g 0004 Viz 08)

Label for Gemcitabine Injection, 1 gram per 26.3 mL (38 mg/mL) solution for intravenous infusion, distributed as a 26.3 mL single-dose vial. The label notes that the product must be diluted before use and includes a caution that it is a cytotoxic agent. The labeler is Meitheal Pharmaceuticals Inc.*

FDA Label Image

Principal Display Panel – Gemcitabine Injection 1 Gram Carton (Gem0g 0004 Viz 09)

Packaging label for Gemcitabine injection 1 gram per 26.3 mL (38 mg/mL) by Meitheal Pharmaceuticals Inc. The label indicates the product is for intravenous infusion only and must be diluted before use. It is supplied in a single-dose vial with storage instructions and a warning that it is a cytotoxic agent. The label also includes regulatory and barcoding information.*

FDA Label Image

Principal Display Panel – Gemcitabine Injection 2 Gram Vial Label (Gem0g 0004 Viz 10)

Gemcitabine Injection, 38 mg/mL, supplied as 2 grams per 52.6 mL in a single-dose vial. Label indicates it is for intravenous infusion only, must be diluted before use, and warns it is a cytotoxic agent. Labeler is Meitheal Pharmaceuticals Inc. The packaging includes handling and storage instructions, and a barcode is visible.*

FDA Label Image

Principal Display Panel – Gemcitabine Injection 2 Gram Carton (Gem0g 0004 Viz 11)

Label for Gemcitabine Injection 2 grams per 52.6 mL (38 mg/mL) for intravenous infusion only, supplied by Meitheal Pharmaceuticals Inc. The label includes storage instructions, a caution that the drug is cytotoxic and must be diluted before use, and packaging details for a single-dose vial of 52.6 mL. The label also features a barcode and the Novaplus trademark.*

* 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.