Norethindrone Acetate And Ethinyl Estradiol
Product Images NDC 75834-130

7 FDA label images from Nivagen Pharmaceuticals, Inc. · 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 Norethindrone Acetate And Ethinyl Estradiol (NDC 75834-130). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Nivagen 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

Chemical Structure (Norethindrone 01)

Chemical Structure (Norethindrone 01)
Chemical structure diagram depicting the molecular structure of the active ingredient, likely representing Norethindrone Acetate, showing its steroid framework with associated functional groups including acetyl and ethynyl moieties.*
FDA Label Image

Chemical Structure (Norethindrone 02)

Chemical Structure (Norethindrone 02)
Chemical structure diagram of the active ingredient shown in the image, depicting the molecular arrangement including hydroxyl groups and a triple bond, consistent with components in norethindrone acetate and ethinyl estradiol formulations.*
FDA Label Image

Figure 1 (Norethindrone 03)

Figure 1 (Norethindrone 03)
Two line graphs showing mean plasma concentrations of Norethindrone and Ethinyl Estradiol over 24 hours. The top graph displays mean plasma Norethindrone concentration (ng/mL) peaking early and declining over time. The bottom graph illustrates mean plasma Ethinyl Estradiol concentration (pg/mL) with a similar pattern, both plotted against time in hours.*
FDA Label Image

Figure 2 (Norethindrone 04)

Figure 2 (Norethindrone 04)
A line graph depicting the percentage of patients over 12 months of treatment with Norethindrone Acetate and Ethinyl Estradiol at two dosages (0.5/2.5 and 1/5) compared to placebo. The x-axis represents months of treatment, and the y-axis shows the percentage of patients, illustrating patient response trends over time for each group.*
FDA Label Image

Figure 3 (Norethindrone 05)

Figure 3 (Norethindrone 05)
A bar chart showing mean percentage change at 12 and 24 months for Placebo, Norethindrone Acetate/Ethinyl Estradiol (NA/EE) 0.5/2.5, and NA/EE 1/5 groups. The chart highlights significant differences with p-values less than 0.001 versus placebo.*
FDA Label Image

Principal Display Panel (1 mg/5 mcg Tablet Blister Pack Carton)

Principal Display Panel (1 mg/5 mcg Tablet Blister Pack Carton)
Packaging label for Norethindrone Acetate and Ethinyl Estradiol Tablets, USP 1 mg/5 mcg by Nivagen Pharmaceuticals, Inc. The label indicates this is a box containing 3 blister cards of 28 tablets each. The package includes dosage strength, NDC number 75834-130-29, and storage instructions. It also displays barcode and regulatory information including 'Rx Only.'*
FDA Label Image

Principal Display Panel (0.5 mg/2.5 mcg Tablet Blister Pack Carton)

Principal Display Panel (0.5 mg/2.5 mcg Tablet Blister Pack Carton)
Packaging label for Norethindrone Acetate and Ethinyl Estradiol Tablets, USP 0.5 mg/2.5 mcg by Nivagen Pharmaceuticals, Inc. The label indicates 3 blister cards each containing 28 tablets. It includes dosage information, NDC number 75834-129-29, directions for use, storage instructions, and manufacturing details, all on a white and light orange background with Nivagen branding.*

* 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.