Nifedipine Tablet, Extended Release
Product Images NDC 51655-386

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Nifedipine (NDC 51655-386). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Northwind Health Company, Llc, 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

Label (51655 386 52 Rev A 03 23)

NIFEdipine is a medication that comes in a 60mg extended-release tablet form. This medication should be kept in its original container, protected from light and moisture, and stored at USP controlled room temperature. It is important to swallow the tablet whole and not to bite or divide it. The medication is Rx-only and the dosage should be followed as instructed in the package insert. The active ingredient Nifedipine is manufactured by Ingenus Pharmaceuticals, LLC and repackaged by Northwind Pharmaceuticals. The lot number is 0000000000, and the medication can be identified with GTIN 00351655386521 and S/N 000000000000000.*

FDA Label Image

01 (Image 01)

FDA Label Image

02 (Image 02)

Nifedipine extended-release tablets may cause adverse effects such as headache, fatigue, dizziness, constipation, and nausea. These effects were reported in 15.8%, 5.9%, 4.1%, 3.3%, and 33% of the 707 patients who took the medication. In comparison, the placebo group reported rates of 9.8%, 4.1%, 4.5%, and 23% for headache, fatigue, dizziness, and constipation, respectively.*

FDA Label Image

03 (Image 03)

This is a table of adverse effects experienced by patients taking Nifedipine Capsules compared to the placebo group. The table lists the percentage of patients who experienced each adverse effect, including dizziness, lightheadedness, and giddiness, flushing and heat sensation, headache, weakness, nausea and heartburn, muscle cramps and tremor, peripheral edema, nervousness and mood changes, palpitations, dyspnea, cough, and wheezing, and nasal congestion and sore throat. The sample sizes for each group are also provided.*

FDA Label Image

04 (Image 04)

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