Fyavolv Tablet, Film Coated
Product Images NDC 68180-827

Product Visual Gallery

This gallery contains 20 technical images submitted to the FDA as part of the official labeling for Fyavolv (NDC 68180-827). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Lupin 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

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Chemical structure of Ethinyl Estradiol, an active ingredient in Fyavolv, a prescription oral tablet containing Norethindrone Acetate and Ethinyl Estradiol. The diagram depicts the molecular structure with rings and functional groups characteristic of this compound.*

FDA Label Image

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Chemical structure diagram of the active ingredient Norethindrone Acetate, showing its molecular framework with rings, hydrogen atoms, and functional groups including a ketone and acetate moiety.*

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A line graph showing the mean plasma norethindrone concentration (ng/mL) over time (hours) after administration. The concentration peaks sharply around 1-2 hours, then gradually declines over a 24-hour period.*

FDA Label Image

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A pharmacokinetic line graph showing mean plasma ethinyl estradiol concentration (pg/mL) over 24 hours. The x-axis represents time in hours, and the y-axis represents ethinyl estradiol concentration in pg/mL. Data points marked with triangles indicate plasma concentration peaks approximately 2 hours after dosing, followed by a gradual decline over the remaining time.*

FDA Label Image

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A line graph comparing the percentage of patients over 12 months of treatment among three groups: Placebo (N=137), Norethindrone Acetate and Ethinyl Estradiol 0.5/2.5 (N=136), and Norethindrone Acetate and Ethinyl Estradiol 1/5 (N=146). The y-axis shows the percentage of patients from 0 to 100%, and the x-axis shows months of treatment from 1 to 12. All three lines show increasing trends over time, with the placebo group having the highest initial percentages.*

FDA Label Image

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A bar chart illustrating mean percent change from baseline in volumetric bone mineral density at the lumbar spine, measured by quantitative computed tomography after 12 and 24 months of treatment. The chart compares placebo, Norethindrone Acetate and Ethinyl Estradiol 0.5/2.5 mg, and Norethindrone Acetate and Ethinyl Estradiol 1/5 mg groups, showing positive bone density changes in treatment groups versus negative changes in placebo at both time points.*

FDA Label Image

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Fyavolv 0.5 mg / 0.0025 mg film-coated tablets packaging label displays the proprietary name and generic names norethindrone acetate and ethinyl estradiol. It includes a 28-tablet monthly pack with dosing perforations. The label shows storage instructions, distributor Lupin Pharmaceuticals Inc., and manufacturer Lupin Limited in India. The label warns the package is not child resistant and advises keeping medications away from children.*

FDA Label Image

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Packaging label for Fyavolv 0.5 mg/0.0025 mg tablets containing norethindrone acetate and ethinyl estradiol USP. The label indicates it is a prescription oral film-coated tablet. The labeler is Lupin Pharmaceuticals, Inc. The package contains 1 wallet of 28 tablets.*

FDA Label Image

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The packaging label for Fyavolv 0.5 mg/0.0025 mg tablets shows the product as norethindrone acetate and ethinyl estradiol tablets USP, film coated and for oral use. The label includes the NDC 68180-827-13, manufacturer Lupin Pharmaceuticals, Inc., and indicates the package contains 3 wallets of 28 tablets each. Additional text instructs to see enclosed patient information including boxed warnings.*

FDA Label Image

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Fyavolv 0.5 mg / 0.0025 mg film-coated tablets label containing norethindrone acetate and ethinyl estradiol USP. The prescription drug is distributed by Lupin Pharmaceuticals, Inc. The label shows a 90-tablet package and includes dosage instructions, storage conditions, and contact information for reporting suspected adverse reactions.*

FDA Label Image

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Packaging label for Fyavolv tablets containing 1 mg norethindrone acetate and 0.005 mg ethinyl estradiol film-coated tablets. The label displays a 28-tablet count with monthly self-breast exam instructions. Manufactured by Lupin Limited, India, and distributed by Lupin Pharmaceuticals, Inc., Baltimore, Maryland. Storage instructions at 25°C with permitted excursions are noted.*

FDA Label Image

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Fyavolv 1 mg/0.005 mg tablets packaging label, containing norethindrone acetate and ethinyl estradiol tablets USP. The label indicates an oral film-coated tablet form, supplied as 1 wallet of 28 tablets. The labeler is Lupin Pharmaceuticals, Inc., featuring the Lupin logo and includes NDC code 68180-828-11 along with medication warnings and barcodes.*

FDA Label Image

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Fyavolv 1 mg/0.005 mg tablets film-coated oral prescription drug packaging label. Contains norethindrone acetate and ethinyl estradiol (USP). The label shows the NDC 68180-828-13, specifies Rx only, and indicates a package count of 3 wallets of 28 tablets each. Distributed by Lupin Pharmaceuticals, Inc., Baltimore, Maryland, and manufactured by Lupin Limited in India. Includes barcode and a note to see enclosed information for patient, including boxed warning.*

FDA Label Image

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Label for Fyavolv tablets containing norethindrone acetate 1 mg and ethinyl estradiol 0.005 mg. Film-coated oral tablets in a package of 90, distributed by Lupin Pharmaceuticals, Inc. The label includes dosage, storage instructions, and contact information for reporting adverse reactions.*

FDA Label Image

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Label for Fyavolv film-coated oral tablets containing norethindrone acetate 0.5 mg and ethinyl estradiol 0.0025 mg. The label includes storage instructions at 25°C (77°F) with permitted excursions, manufacturer Lupin Limited India, and distributor Lupin Pharmaceuticals, Inc., Baltimore. The label also features a barcode, lot number, expiration date fields, and a reminder for monthly self breast exams.*

FDA Label Image

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Packaging label for Fyavolv tablets containing 0.5 mg norethindrone acetate and 0.0025 mg ethinyl estradiol. The label indicates the product is film-coated tablets for oral use, supplied in a blister pack of 28 tablets. Manufactured and distributed by Lupin Pharmaceuticals, Inc.*

FDA Label Image

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Packaging label for Fyavolv tablets containing norethindrone acetate and ethinyl estradiol USP, 0.5 mg/0.0025 mg strength. The film-coated tablets are supplied by Lupin Pharmaceuticals, Inc. The package includes 3 blisters with 28 tablets each and indicates prescription use only. The label includes NDC 68180-827-73 and manufacturer information from Lupin Limited, India.*

FDA Label Image

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Label for Fyavolv film-coated tablets containing norethindrone acetate and ethinyl estradiol, 1 mg/0.005 mg strength. Distributed by Lupin Pharmaceuticals, Inc., Baltimore, Maryland, and manufactured by Lupin Limited in India. Label includes storage instructions and a barcode, with emphasis on monthly self breast exam.*

FDA Label Image

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Packaging label for Fyavolv 1 mg/0.005 mg film-coated tablets containing norethindrone acetate and ethinyl estradiol. The label indicates the product is a prescription human drug with one blister pack containing 28 tablets. The labeler is Lupin Pharmaceuticals, Inc., with a blue and pink gradient background and a Lupin logo at the top right.*

FDA Label Image

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Packaging label for Fyavolv tablets, containing norethindrone acetate and ethinyl estradiol, each tablet with strengths of 1 mg and 0.005 mg, respectively. The label shows a box of 3 blisters, each with 28 film-coated oral tablets. The product is marketed by Lupin Pharmaceuticals, Inc. with NDC 68180-828-73.*

* 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.