Balcoltra Kit
Product Images NDC 75854-602

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 7 technical images submitted to the FDA as part of the official labeling for Balcoltra (NDC 75854-602). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avion Pharmaceuticals, 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

Molecular Structures (Image 01)

Molecular Structures (Image 01)
Levonorgestrel Ethinyl Estradiol are two types of female hormones that are used in combination as a form of birth control. The first chemical, Levonorgestrel, belongs to a class of drugs known as progestins and the second chemical, Ethinyl Estradiol, belongs to a class of drugs known as estrogens. These hormones prevent ovulation and make it difficult for sperm to reach the egg, therefore reducing the chances of pregnancy. The molecular formula and weight of Levonorgestrel is CyuHy0 with a weight of 3124, while the molecular formula and weight of Ethinyl Estradiol is CyuHnO with a weight of 296.4.*
FDA Label Image

Figure 2 (Image 02)

FDA Label Image

How Does Balcoltra Work For Contraception (Image 03)

FDA Label Image

Instructions For Use (Figure 1)

FDA Label Image

Instructions For Use (Figure 2)

Instructions For Use (Figure 2)
The text provides a direction on how to take pills, “FROM LEFT TO RIGHT EACH WEEK” and mentions “Figure B”. It is likely a part of a medication package insert or prescription label.*
FDA Label Image

Principal Display Panel (Carton Front)

Principal Display Panel (Carton Front)
S Balcoltra is a 28-day regimen birth control pill that prevents pregnancy. It contains levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets. It does not protect against HIV or other sexually transmitted diseases. The product is available in 1 blister pack with 28 tablets, and its NDC is 75854-602-28. Women who are over 35 years old and smoke have a higher risk of serious cardiovascular events from the combination of oral contraceptives.*
FDA Label Image

Principal Display Panel (Carton Back)

Principal Display Panel (Carton Back)
This is a description of a medication called Balcoltra contained in a blister pack with 28 tablets to be used in a 28-day regimen. Each pack contains a combination of hormones and instructions for use, which should be included with each dispenser. The medication comprises 21 orange tablets containing vonorgestrel and ethinylestradiol and 7 blue placebo tablets containing ferrous bisglycinate. The medication is to be used once daily for two consecutive days, followed by one blue placebo tablet for seven consecutive days. The medication's usual dose is indicated, and the prescribing information is provided. It should be kept out of reach of children, and in case of accidental overdose, a physician or poison control center should be contacted. The manufacturer is AbnPamceuicals LLC in Alpharetta, GA, and Novut Laboataies in Nantong, China.*

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