Arformoterol Tartrate Solution
Product Images NDC 69097-168

15 FDA label images from Cipla Usa Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Arformoterol Tartrate (NDC 69097-168). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Cipla 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

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Chemical structure of arformoterol tartrate, showing the molecular arrangement of the active ingredient in the inhalation solution product by Cipla USA Inc.*
FDA Label Image

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A line chart titled 'Mean Change in FEV1 Over Time for Clinical Trial A at Week 0 (Day 1)' showing mean change from baseline FEV1 in liters on the vertical axis and hours postdose on the horizontal axis. The graph displays two data series with markers indicating changes in FEV1 over a 12-hour period after dosing.*
FDA Label Image

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A line chart titled 'Mean Change in FEV1 Over Time for Clinical Trial A at Week 12' showing mean change from baseline FEV1 (in liters) plotted against hours postdose. Two data series are displayed with different markers, one with pink squares showing a positive increase in FEV1 peaking early and then gradually decreasing, and another with blue diamonds staying near zero with a slight decline over time, covering a 12-hour postdose period.*
FDA Label Image

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A figure legend explaining a chart comparing baseline FEV1 (L) values for two groups: placebo (ITT n=143) with a baseline FEV1 of 1.20 L and 15 mcg arformoterol tartrate twice daily (BID, ITT n=141) with a baseline FEV1 of 1.15 L.*
FDA Label Image

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An instructional black and white line drawing showing hands opening a unit-dose vial. One hand holds the vial, and the other rotates the top cap counterclockwise to remove it, illustrating how to open the vial for use.*
FDA Label Image

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An instructional diagram showing a hand holding a respiratory solution device above a reservoir component, illustrating proper assembly or use of the inhalation solution device. The reservoir is labeled, and the diagram focuses on the connection between the solution device and the reservoir.*
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Two illustrations showing respiratory inhalation device components: Figure 3 depicts a mouthpiece attached to the inhalation device, while Figure 4 shows a face mask attached to the same type of device, intended for delivering the medication by inhalation.*
FDA Label Image

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An instructional black-and-white line drawing showing a compressor device with labeled components. The device front panel features a knob, a rectangular display or window, and a connected tubing at the lower front. Labels identify the compressor and tubing connection points, indicating setup for respiratory inhalation use.*
FDA Label Image

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An instructional illustration showing a person using a respiratory inhalation device by placing the mouthpiece in the mouth, demonstrating how to correctly inhale the medication solution.*
FDA Label Image

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The label for arformoterol tartrate inhalation solution by Cipla USA Inc. shows a 15 mcg/2 mL strength in a sterile unit-dose vial format. The packaging indicates 5 x 2 mL vials, with instructions for storage and disposal. It includes dosage details, lot and expiration date fields, and a barcode with NDC 69097-168-48.*
FDA Label Image

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The packaging label for arformoterol tartrate inhalation solution displays the strength as 15 mcg per 2 mL. The label states it is for oral inhalation only and includes storage instructions to keep refrigerated or at room temperature for up to 6 weeks. The package contains 60 sterile unit-dose vials (12 packs of 5 vials). The labeler is Cipla USA Inc. The NDC is 69097-168-64.*
FDA Label Image

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The packaging label for Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL by Cipla USA Inc. The label includes dosage form and strength, a note indicating potency as the fumarate, Rx only status, storage instructions to keep refrigerated or at room temperature up to 6 weeks, and the container quantity of thirty 2 mL single-dose vials. NDC 69097-168-87 is shown along with barcode and manufacturing details.*
FDA Label Image

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Labels for arformoterol tartrate inhalation solution 15 mcg/2 mL by Cipla USA Inc. The top label (front) shows the drug name, dosage strength, and manufacturer. The back of the top label lists the drug composition and potency expressed as arformoterol. The bottom label (front) provides storage instructions, handling precautions, and usage warnings. The labels are primarily white with purple and blue highlights.*
FDA Label Image

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Packaging label for arformoterol tartrate inhalation solution 15 mcg*/2 mL by Cipla USA Inc. The label includes the product name, strength, dosage form, storage instructions, and packaging details of 30 x 2 mL sterile unit-dose vials in foil pouches. Additional instructions emphasize refrigeration or room temperature storage for up to 6 weeks and restriction to oral inhalation. The label shows the NDC 69097-168-53 and includes a barcode.*

* 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.