Balcoltra Kit
Product Images NDC 75854-602

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)

Chemical structure diagrams of Levonorgestrel and Ethinyl Estradiol with their molecular formulas and molecular weights shown. Levonorgestrel is depicted with formula C21H28O2 and MW 312.4, Ethinyl Estradiol with formula C20H24O2 and MW 296.4.*

FDA Label Image

Figure 2 (Image 02)

Two line graphs depicting the concentration of levonorgestrel and ethinyl estradiol over time in hours. The upper graph shows levonorgestrel concentration (pg/mL) decreasing sharply from near 6000 to near 0 over 96 hours. The lower graph shows ethinyl estradiol concentration (pg/mL) decreasing from about 150 to near 0 over the same 96-hour period. Both include error bars.*

FDA Label Image

How Does Balcoltra Work For Contraception (Image 03)

An illustration showing the comparative effectiveness of various contraceptive methods. It features a vertical arrow labeled 'Fewer pregnancies' at the top to 'More pregnancies' at the bottom, alongside corresponding pregnancy rates per 100 women per year. The methods are grouped in boxes from highly effective (implants, injections, intrauterine devices, sterilization) to moderate (birth control pills, skin patch, vaginal ring with hormones), less effective (condoms, diaphragm), least effective (no sex during fertile days, spermicide, withdrawal), and no birth control.*

FDA Label Image

Instructions For Use (Figure 1)

Balcoltra kit containing levonorgestrel and ethinyl estradiol tablets shown as a 28-day blister card. The pack includes 21 active orange tablets arranged from Sunday to Saturday over three weeks, followed by 7 inactive blue tablets for week four. The label instructs taking pills from left to right each week and is labeled by Avion Pharmaceuticals.*

FDA Label Image

Instructions For Use (Figure 2)

An instructional illustration showing a hand holding a strip of birth control pills from Balcoltra (levonorgestrel and ethinyl estradiol). It depicts taking the pills in a left-to-right direction each week, with days of the week labeled on a sliding tab. The strip contains three rows of orange (active) pills and one row of blue (inactive) pills, visually guiding the sequence for daily use.*

FDA Label Image

Principal Display Panel (Carton Front)

Balcoltra kit containing levonorgestrel and ethinyl estradiol tablets, USP, and ferrous bisglycinate tablets with strengths of 0.1 mg/0.02 mg and 36.5 mg. The package includes 1 blister pack with 28 tablets for a 28-day regimen. Labeler is Avion Pharmaceuticals. The label also states it is Rx only and includes a warning that the product prevents pregnancy but does not protect against HIV or other sexually transmitted diseases.*

FDA Label Image

Principal Display Panel (Carton Back)

The image shows a detailed drug information panel for Balcoltra, a kit containing levonorgestrel and ethinyl estradiol tablets along with ferrous bisglycinate tablets. It includes dosage instructions, storage conditions, warnings about iron overdose, and manufacturer and labeler details from Avion Pharmaceuticals. The panel specifies a 28-tablet blister pack for a 28-day regimen.*

* 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.