Orkambi Granule
Product Images NDC 51167-122

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Orkambi (NDC 51167-122). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Vertex Pharmaceuticals Incorporated, 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 (Orkambi 01)

Chemical structure diagram of the active ingredients lumacaftor and ivacaftor, showing the molecular arrangement of atoms and bonds representing their combined chemical composition.*

FDA Label Image

Chemical Structure (Orkambi 02)

Chemical structure diagram of the active ingredient lumacaftor, part of the combination drug Orkambi (lumacaftor and ivacaftor). The structure shows molecular bonds and chemical groups characteristic of lumacaftor.*

FDA Label Image

Figure 1 (Orkambi 03)

A line graph titled 'Trial 1' showing absolute change in ppFEV1 over time from baseline (BL) to Week 24. It compares two groups: Placebo and LUM 400 mg q12h/IVA 250 mg q12h. The y-axis represents absolute change with values from -2 to 5; the x-axis marks visits at BL, Day 15, Week 4, Week 8, Week 16, and Week 24. Data includes error bars indicating 95% confidence intervals.*

FDA Label Image

Figure 1 (Orkambi 04)

A line graph titled "Trial 2" showing absolute change in ppFEV1 over time (baseline, Day 15, Weeks 4, 8, 16, and 24) for two groups: Placebo and LUM 400 mg q12h/IVA 250 mg q12h. The LUM/IVA group shows a consistent positive increase peaking around Week 8, while the Placebo group remains near zero throughout. Error bars indicate the 95% confidence interval at each visit.*

FDA Label Image

Principal Display Panel (200 mg/125 mg Tablet Blister Pack Carton Box)

Packaging label for ORKAMBI tablets containing lumacaftor and ivacaftor, 200 mg/125 mg per tablet, manufactured by Vertex Pharmaceuticals Incorporated. The label states a package size of 112 tablets and includes storage instructions to keep at controlled room temperature. The design features a white background with multicolored circular graphics and the ORKAMBI logo prominently displayed.*

FDA Label Image

Principal Display Panel (100 mg/125 mg Tablet Blister Pack Carton Box)

ORKAMBI 100 mg/125 mg tablets packaging label for oral use. The label displays the proprietary name ORKAMBI with the generic names lumacaftor and ivacaftor. The box is designed to hold 112 tablets and is manufactured by Vertex Pharmaceuticals Incorporated. The label shows the dosage strength prominently and includes storage instructions and regulatory information.*

FDA Label Image

Principal Display Panel (100 mg/125 mg Granule Packet Carton)

ORKAMBI 100 mg/125 mg oral granules packaging label for lumacaftor and ivacaftor by Vertex Pharmaceuticals Incorporated. The carton holds 56 packets, with dosing instructions indicating two doses 12 hours apart. The label shows product name, active ingredients, strengths, dosage form, package count, and storage conditions.*

FDA Label Image

Principal Display Panel (150 mg/188 mg Granule Packet Carton)

Packaging label for ORKAMBI (lumacaftor and ivacaftor) oral granules, 150 mg/188 mg per packet, by Vertex Pharmaceuticals Incorporated. The carton contains 56 packets, packaged as 4 wallets with 14 packets each. The label includes storage instructions, Rx only designation, and dosing reminder graphics for morning and evening use.*

FDA Label Image

Principal Display Panel (75 mg/94 mg Granule Packet Carton)

ORKAMBI (lumacaftor/ivacaftor) oral granules 75 mg / 94 mg per packet in a carton. The packaging indicates the product contains 56 packets divided into 4 individual wallets, each with 14 packets. The label includes dosing instructions to take one packet every 12 hours, and storage information for controlled room temperature. Labeler is Vertex Pharmaceuticals Incorporated.*

* 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.