Afirmelle Kit
Product Images NDC 65862-849

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Afirmelle (NDC 65862-849). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Aurobindo Pharma Limited, 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

Figure I: Mean (se) Levonorgestrel And Ethinyl Estradiol Serum Concentrations In 22 Subjects Receiving Levonorgestrel And Ethinyl Estradiol (100 Mcg Levonorgestrel And 20 Mcg Ethinyl Estradiol) (Levo Ethi Fig1)

Figure I: Mean (se) Levonorgestrel And Ethinyl Estradiol Serum Concentrations In 22 Subjects Receiving Levonorgestrel And Ethinyl Estradiol (100 Mcg Levonorgestrel And  20 Mcg Ethinyl Estradiol) (Levo Ethi Fig1)
Pharmacokinetic concentration-time profiles of Levonorgestrel and Ethinyl Estradiol after dosing. Two line graphs show concentration (ng/mL) on the y-axis versus time (hours) on the x-axis for each drug on Days 1, 6, and 21, illustrating changes over approximately 72 hours.*
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Circulatory Disease Mortality Rates Per 100,000 Woman Years By Age, Smoking Status And Oral-contraceptive Use (Levo Ethi Fig2)

Circulatory Disease Mortality Rates Per 100,000 Woman Years By Age, Smoking Status And Oral-contraceptive Use (Levo Ethi Fig2)
A bar chart showing circulatory disease mortality rates per 100,000 woman years categorized by age groups (15-24, 25-34, 35-44, 45+) and separated by smoking status and oral contraceptive use. Four groups are represented: ever-users nonsmokers, controls nonsmokers, ever-users smokers, and controls smokers, with rates increasing notably in older age groups, particularly among ever-users who smoke.*
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In What Order To Take The Pills (Levo Ethi Fig3)

In What Order To Take The Pills (Levo Ethi Fig3)
A forest plot displaying effect estimates (OR/RR) with 95% confidence intervals from multiple studies related to contraceptive use, including studies by NICHD, French E3N cohort, Shangai Women's Health, Nurses' Health II, Oxford Family Planning Association, and Danish Sex Hormone Register from 2002 to 2017. Each study's point estimate and interval are shown on a horizontal axis ranging from -1.5 to 2. This chart compares risk or odds ratios for ever or current use in various cohorts.*
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Pick The Day Label Strip (Levo Ethi Fig4)

Pick The Day Label Strip (Levo Ethi Fig4)
The image shows a calendar-style blister pack insert for Afirmelle, a kit containing Levonorgestrel and Ethinyl Estradiol tablets USP 0.1 mg/0.02 mg. It illustrates the pill regimen by day of the week, with three rows of white to off-white pills and one row of green pills. Arrows indicate the order to take the tablets, starting from Sunday and continuing through Saturday in four rows.*
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Package Label-principal Display Panel (0.1 mg/0.02 mg (28 Tablets Pouch))

Package Label-principal Display Panel (0.1 mg/0.02 mg (28 Tablets Pouch))
An instructional diagram showing how to apply a day label strip to a pill card for Afirmelle (Levonorgestrel and Ethinyl Estradiol) tablets, 0.1 mg/0.02 mg strength. It illustrates selecting the correct day label, peeling it, and placing it on the card to track daily tablet intake, with rows of white to off-white and green tablet positions marked.*
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Package Label-principal Display Panel (0.1 mg/0.02 mg (Contains 6 Pouches of 28 Tablets Each))

Package Label-principal Display Panel (0.1 mg/0.02 mg (Contains 6 Pouches of 28 Tablets Each))
A medication cycle chart from the Afirmelle kit, showing four rows of tablets arranged by day of the week (Sunday to Saturday). The first three rows consist of white to off-white tablets, and the fourth row includes green tablets. Arrows indicate the daily pill-taking order, starting at the first white tablet. Text specifies the product as Afirmelle (Levonorgestrel and Ethinyl Estradiol) tablets USP 0.1 mg/0.02 mg.*
FDA Label Image

Levo Ethi Fig7

Levo Ethi Fig7
An instructional diagram demonstrating how to apply a day label to a weekly pill blister pack for Afirmelle (Levonorgestrel and Ethinyl Estradiol) Tablets USP 0.1 mg/0.02 mg. The image shows a hand peeling a day label strip to align with the days of the week on the blister, indicating how to track daily medication intake. The blister pack features circular pill compartments arranged in four rows, with the last row pills shaded green and labeled inactive tablets for week 4.*
FDA Label Image

Levo Ethi Fig8

Levo Ethi Fig8
Afirmelle kit packaging label displaying Levonorgestrel and Ethinyl Estradiol tablets USP, 0.1 mg/0.02 mg strength. The label includes dosing information for a 28-day regimen with 28 tablets per blister card, patient usage instructions, storage conditions, and the labeler Aurobindo Pharma Limited. It also notes the product is an oral contraceptive and is Rx only.*
FDA Label Image

Levo Ethi Fig9

Levo Ethi Fig9
Afirmelle (Levonorgestrel and Ethinyl Estradiol) Tablets USP 0.1 mg/0.02 mg kit packaging label. The label indicates a 28-day regimen containing 6 pouches of 28 tablets each. It includes white to off-white tablets with active ingredients levonorgestrel and ethinyl estradiol, and green inert tablets. Distributed by Aurobindo Pharma USA, Inc., made in India, with NDC 65862-849-92.*
FDA Label Image

Chemical Structure (Levo Ethi Str)

Chemical Structure (Levo Ethi Str)
Chemical structures depicting the active ingredients Levonorgestrel and Ethinyl Estradiol in Afirmelle. The diagrams show the molecular framework including rings and functional groups characteristic of these hormones.*

* 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.