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.

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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)

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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)
This is a table showing circulatory disease mortality rates per 100,000 woman years by age, smoking status, and oral-contraceptive use for ever-users/non-smokers and ever-users/smokers. There are several age ranges included in the table, but it is unclear what the numbers on the right side of the table (1524, 253, etc.) represent.*
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In What Order To Take The Pills (Levo Ethi Fig3)

In What Order To Take The Pills (Levo Ethi Fig3)
This appears to be a list of different studies conducted between 2002 and 2017 analyzing the use of contraceptive methods among women. Some studies focused on ever-use while others examined current use. The last two lines contain effect estimates in the form of odds ratios or relative risks, possibly for different contraceptive methods. However, it is unclear what these numbers refer to or what the "s 4 a5 0" and "05" mean.*
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Pick The Day Label Strip (Levo Ethi Fig4)

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Package Label-principal Display Panel (0.1 mg/0.02 mg (28 Tablets Pouch))

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Package Label-principal Display Panel (0.1 mg/0.02 mg (Contains 6 Pouches of 28 Tablets Each))

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Levo Ethi Fig7

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Levo Ethi Fig8

Levo Ethi Fig8
This is a description of a 28-day regimen package of Afirmelle, which contains levonorgestrel and ethinyl estradiol tablets prescribed for preventing pregnancy. The package contains 1 blister card of 28 tablets to be taken in a prescribed manner. It also warns that the product is not intended to protect against HIV infection and other sexually transmitted diseases. The text also includes information on the package not being child-resistant and advises parents to keep medication out of children's reach.*
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Levo Ethi Fig9

Levo Ethi Fig9
This is a description of Afirmelleā„¢, a 28-day oral contraceptive medication that contains Levonorgestrel and Ethinyl Estradiol in a 21+7 regimen. Each pouch contains detailed patient labeling and a patient package insert, which must be included with each package dispensed. The medication is intended to prevent pregnancy but does not protect against HIV/AIDS and other sexually transmitted diseases. Each tablet has a specific dosage according to a prescribed schedule. The medication should be stored at a controlled room temperature and kept out of reach of children. It is distributed by Aurobindo Pharma USA and manufactured in India.*
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Chemical Structure (Levo Ethi Str)

Chemical Structure (Levo Ethi Str)
Ethinyl Estradiol is a synthetic estrogen commonly used in combination with progestin in hormonal contraceptives. It is also sometimes used in the treatment of hormonal imbalances and menopausal symptoms.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.