Zoledronic Acid Injection, Solution, Concentrate
Product Images NDC 0143-9642

6 FDA label images from Hikma Pharmaceuticals Usa Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Zoledronic Acid (NDC 0143-9642). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma Pharmaceuticals Usa 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

Chemical Structure (Zoledronic Acid Injection 1)

Chemical Structure (Zoledronic Acid Injection 1)
Chemical structure of zoledronic acid, showing its bisphosphonate molecular framework with two phosphonic acid groups and an imidazole ring.*
FDA Label Image

Cockcroft-gault Formula (Zoledronic Acid Injection 2)

Cockcroft-gault Formula (Zoledronic Acid Injection 2)
A mathematical formula calculating creatinine clearance (CrCl) based on age, weight, serum creatinine, and a gender adjustment factor. The formula includes subtraction of age from 140, multiplication by weight and 0.85 for females, and division by serum creatinine times 72.*
FDA Label Image

Figure 1 Proportion Of Complete Responders By Day 10 In Pooled Hcm Studies (Zoledronic Acid Injection 3)

Figure 1 Proportion Of Complete Responders By Day 10 In Pooled Hcm Studies (Zoledronic Acid Injection 3)
A bar graph titled 'Proportion of Complete Responders by Day 10 in Pooled HCM Studies' comparing the percentage of complete responders between zoledronic acid injection 4 mg (n=86) and pamidronate 90 mg (n=99). The graph shows a higher response rate for zoledronic acid, with a p-value of 0.002 indicating statistical significance.*
FDA Label Image

Ndc 0143-9642-01 Zoledronic Acid Injection 4 mg/5 mL (0.8 mg/ml) Sterile Concentrate Concentrate For Intravenous Infusion Rx Only 5 mL Single Dose Vial Not For Direct Injection. Dose Must Be Diluted. Do Not Mix With Calcium-containing Infusion Solutions. Usual Dosage: See Package Insert. Discard Unused Portion. Store At 25º (77ºf); Excursions Permitted To 15º To 30ºc (59º To 86ºf) [see Usp Controlled Room Temperature]. (Zoledronic Acid Injection 4)

Ndc 0143-9642-01 Zoledronic Acid Injection 4 mg/5 mL (0.8 mg/ml) Sterile Concentrate Concentrate For Intravenous Infusion Rx Only 5 mL Single Dose Vial Not For Direct Injection. Dose Must Be Diluted. Do Not Mix With Calcium-containing Infusion Solutions. Usual Dosage: See Package Insert. Discard Unused Portion. Store At 25º (77ºf); Excursions Permitted To 15º To 30ºc (59º To 86ºf) [see Usp Controlled Room Temperature]. (Zoledronic Acid Injection 4)
Label for Zoledronic Acid Injection 4 mg per 5 mL (0.8 mg/mL) sterile concentrate for intravenous infusion by Hikma Pharmaceuticals USA Inc. The label includes instructions that the dose must be diluted, storage conditions, and manufacturer information. The vial size is 5 mL single dose.*
FDA Label Image

Zoledronic Acid Injection 5

Zoledronic Acid Injection 5
Zoledronic Acid Injection 4 mg per 5 mL (0.8 mg/mL) sterile concentrate for intravenous infusion, supplied as a 5 mL single dose vial. The label states the product is not for direct injection and must be diluted. It is manufactured by Hikma Farmacêutica in Portugal and distributed by Hikma Pharmaceuticals USA Inc. The label includes storage instructions and dilution details.*
FDA Label Image

Zoledronic Acid Injection 6

Zoledronic Acid Injection 6
Zoledronic Acid 4 mg/5 mL injection label for intravenous use by Hikma Pharmaceuticals USA Inc. The label includes a QR code and displays GTIN, serial number (SN), expiration date (EXP), and lot number (LOT) information fields clearly, intended for product identification and traceability.*

* 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.