Amlodipine Besylate
Product Images NDC 67046-019

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Amlodipine Besylate (NDC 67046-019). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Contract Pharmacy Services-pa, 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

8352ab43-figure-01 (8352ab43 Figure 01)

FDA Label Image

8352ab43-figure-02 (8352ab43 Figure 02)

8352ab43-figure-02 (8352ab43 Figure 02)
This is a survival analysis output, showing the event rate over time (in months) for a particular treatment (Amiodipine) compared to another treatment, along with the hazard ratio and p-value. The hazard ratio suggests that patients on Amiodipine have a lower risk of experiencing the event compared to the other treatment.*
FDA Label Image

8352ab43-figure-03 (8352ab43 Figure 03)

8352ab43-figure-03 (8352ab43 Figure 03)
This appears to be a table or chart with some data points and labels, followed by a single text line stating the mean sitting baseline SBP as 120 mmHg. It is unclear what the table is displaying without more context. Therefore, a useful description cannot be generated.*
FDA Label Image

8352ab43-figure-05 (8352ab43 Figure 05)

8352ab43-figure-05 (8352ab43 Figure 05)
Amlodipine, sold as 5mg tablets, is a medication used to treat high blood pressure and chest pain (angina). Each tablet contains amiodipine besylate, USP equivalent to 5 mg amlodipine. It should be stored at a controlled room temperature of 20-25°C (56°-77°F) and dispensed under prescription only. This particular package has Lot #11508169 and the National Drug Code is 67046-018-30. The expiration date is 11/02/16. Full prescribing information is available in the package insert.*
FDA Label Image

8352ab43-figure-06 (8352ab43 Figure 06)

8352ab43-figure-06 (8352ab43 Figure 06)
The text describes a medication called Amlodipine in the form of tablets with a strength of 10mg. The medication is available in a package that contains 30 tablets. The tablets are marked with an identification code "1G 239" and are to be used only with a valid prescription. The lot number of this specific package is 11506313 and the medication will expire on 09/10/16. The medication should be stored at temperatures between 20°-25°C (68°-77°F). There is additional information available in the package insert. The medication has been packaged by Contract Pharmacy Services-PA and the CPSNDC number for this medication is 67046-018-30.*
FDA Label Image

Table1 (Tab1)

Table1 (Tab1)
This appears to be a list of side effects and dosage information for different medications. The medications mentioned are Amlodipine and Placebo. Amlodipine is available in doses of 2.5mg, 5mg, and 10mg. The text lists side effects such as edema, dizziness, flushing, and palpitation, along with percentages for each dose. The placebo is also mentioned with its associated side effects and percentages.*
FDA Label Image

Table2 (Tab2)

Table2 (Tab2)
This text provides a comparison between the side effects of Amlodipine besylate tablets and a placebo. The percentages indicate how many people experienced each side effect out of a group of 1730 people who took Amlodipine besylate tablets and 1250 people who took a placebo. The side effects listed are fatigue, nausea, abdominal pain, and somnolence.*
FDA Label Image

Table3 (Tab3)

Table3 (Tab3)
The text mentions the side effects of Amlodipine besylate tablets including edema, flushing, palpitations, and somnolence. It also provides data on the percentage of males and females who experienced each side effect when taking the medication versus a placebo.*

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