Estradiol / Norethindrone Acetate Tablet, Film Coated
Product Images NDC 51991-623

12 FDA label images from Breckenridge Pharmaceutical, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Estradiol / Norethindrone Acetate (NDC 51991-623). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Breckenridge Pharmaceutical, 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

Norethindrone 01

Norethindrone 01
Chemical structure of Estradiol, a component of the medication Estradiol / Norethindrone Acetate. The structure shows the molecular composition with hydroxyl groups and the characteristic four-ring steroid framework.*
FDA Label Image

Norethindrone 02

Norethindrone 02
Chemical structure diagram showing the molecular structure of Estradiol Acetate, one of the active ingredients in Estradiol and Norethindrone Acetate tablets by Breckenridge Pharmaceutical, Inc. The structure displays the steroid core with specific substituents highlighted.*
FDA Label Image

Norethindrone 03

Norethindrone 03
A line graph depicting the plasma concentration (pg/ml) of Estradiol and Estrone over time (hours) following administration. Estradiol levels show a peak between 2 to 4 hours then decline, while Estrone exhibits a sharp rise to a higher peak before gradually decreasing over 24 hours.*
FDA Label Image

Norethindrone 04

Norethindrone 04
A pharmacokinetic concentration-time curve showing drug concentration (ng/ml) on the vertical axis and time (hours) on the horizontal axis. The graph depicts how drug levels change over 24 hours following administration.*
FDA Label Image

Norethindrone 05

Norethindrone 05
A line graph comparing the number of moderate to severe hot flushes per week over 12 weeks among three groups: Placebo (dotted line with circles), 1 mg Estradiol (solid line with squares), and Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg (solid line with triangles). The graph shows a decline in hot flush frequency over time for both active treatment groups compared to placebo.*
FDA Label Image

Norethindrone 06

Norethindrone 06
A line graph comparing the number of moderate to severe hot flushes over 12 weeks between Estradiol/Norethindrone Acetate Tablets 0.5 mg/0.1 mg and placebo groups. The vertical axis shows the number of hot flushes, and the horizontal axis represents weeks. The graph shows a decline in hot flushes for the Estradiol/Norethindrone Acetate group compared to a slower decline for the placebo group.*
FDA Label Image

Norethindrone 07

Norethindrone 07
Line graph charting the percentage of women over 12 cycles comparing Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg (n=290) to another group labeled E2 (n=293). The x-axis represents the cycle number from 1 to 12, and the y-axis shows the percentage of women ranging from 40% to over 90%. Two lines with data points illustrate the trend for each group across cycles.*
FDA Label Image

Norethindrone 08

Norethindrone 08
A line graph comparing the percentage of women responding over time between Estradiol/Norethindrone Acetate Tablets 0.5 mg/0.1 mg and placebo groups. The x-axis shows time from 1 to 6 units, and the y-axis represents the percentage of women from 40% to 100%. Two lines indicate a gradual increase in response for both groups, with placebo showing a higher percentage throughout.*
FDA Label Image

Norethindrone 09

Norethindrone 09
A line graph showing percentage change over time in lunar months (28-day cycles) for various treatment groups, including Estradiol/Norethindrone Acetate Tablets 1.0 mg/0.5 mg in EU and US, Estradiol 0.5 mg in US, and Placebo in EU and US. The graph includes markers for each group and error bars indicating variability.*
FDA Label Image

Norethindrone 10

Norethindrone 10
An instructional diagram showing an example dispenser for Estradiol/Norethindrone Acetate 1.0 mg/0.5 mg film-coated tablets. The dispenser layout includes labeled rows and columns for days of the week with instructions on beginning the regimen, daily tablet intake, and end of regimen guidance correlating to the day of the week. The manufacturer, Breckenridge Pharmaceutical, Inc., is noted on the dispenser.*
FDA Label Image

Norethindrone 11

Norethindrone 11
Packaging label for Estradiol / Norethindrone Acetate Tablets, 1.0 mg / 0.5 mg strength, film-coated oral tablets. The label indicates a quantity of 28 tablets, distributed by Breckenridge Pharmaceutical, Inc., and includes barcodes and manufacturer information for Pharmaceuticals International, Inc. The label includes dosage strength prominently on the front panel.*
FDA Label Image

Norethindrone 12

Norethindrone 12
Packaging label for Estradiol / Norethindrone Acetate Tablets, 0.5 mg / 0.1 mg strength, film-coated oral tablets. The label shows the product name, dosage strengths, NDC 51991-623-28, and quantity of 28 tablets. It is distributed by Breckenridge Pharmaceutical, Inc., and manufactured by another pharmaceutical company. The label includes storage instructions and a warning about its use.*

* 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.