Amlodipine And Atorvastatin Tablet, Film Coated
Product Images NDC 60505-3478

15 FDA label images from Apotex Corp. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Amlodipine And Atorvastatin (NDC 60505-3478). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Apotex Corp., 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

Lbl10-10mg30s.jpg (Lbl10 10mg30s)

Lbl10-10mg30s.jpg (Lbl10 10mg30s)
A package label for Amlodipine and Atorvastatin Tablets, USP, showing a strength of 10 mg/10 mg. The label indicates a count of 30 film-coated tablets, manufactured by Apotex Inc., Toronto, Ontario, and labeled by Apotex Corp., Weston, Florida. Storage instructions and dosage warnings are also visible.*
FDA Label Image

Lbl10-20mg30s.jpg (Lbl10 20mg30s)

Lbl10-20mg30s.jpg (Lbl10 20mg30s)
Packaging label for Amlodipine and Atorvastatin Tablets, USP, 10 mg/20 mg strength. The label states the product contains 30 film-coated tablets, manufactured by Apotex Inc. in Toronto, Ontario, and labeled for Apotex Corp. in Weston, Florida. It includes storage instructions, dosage form, and a barcode.*
FDA Label Image

Lbl10-40mg30s.jpg (Lbl10 40mg30s)

Lbl10-40mg30s.jpg (Lbl10 40mg30s)
Label for Amlodipine and Atorvastatin Tablets, USP, film-coated tablets in 10 mg/40 mg strength. The package contains 30 tablets. Manufactured by Apotex Inc., Toronto, Ontario, and labeled by Apotex Corp., Weston, Florida. The label includes storage instructions and dosage directions referencing the package insert.*
FDA Label Image

Lbl10-80mg30s.jpg (Lbl10 80mg30s)

Lbl10-80mg30s.jpg (Lbl10 80mg30s)
Label for Amlodipine and Atorvastatin Tablets USP, 10 mg/80 mg strength, film-coated tablets in a 30-count package. The label shows the product name, strength, prescription status, and manufacturer information for Apotex Corp. Storage instructions and dosage guidance references are also included along with a barcode.*
FDA Label Image

Lbl5-10mg30s.jpg (Lbl5 10mg30s)

Lbl5-10mg30s.jpg (Lbl5 10mg30s)
Amlodipine and Atorvastatin Tablets, USP 5 mg/10 mg film-coated tablets label by Apotex Corp. The label includes storage instructions, dosage information referencing the package insert, and manufacturer details. Package contains 30 tablets with NDC 60505-3478-3 and a barcode.*
FDA Label Image

Lbl5-20mg30s.jpg (Lbl5 20mg30s)

Lbl5-20mg30s.jpg (Lbl5 20mg30s)
Label for Amlodipine and Atorvastatin Tablets, USP, filmy coated tablets with strength 5 mg/20 mg. The label indicates a package count of 30 tablets. It is manufactured by Apotex Inc., Toronto, Canada, and labeled by Apotex Corp., Weston, Florida. Storage instructions and dosage guidance are also visible.*
FDA Label Image

Lbl5-40mg30s.jpg (Lbl5 40mg30s)

Lbl5-40mg30s.jpg (Lbl5 40mg30s)
Packaging label for Amlodipine and Atorvastatin Tablets, USP, strength 5 mg/40 mg, film-coated oral tablets. The label indicates a quantity of 30 tablets. Manufactured by Apotex Inc., Toronto, and labeled for Apotex Corp., Weston, Florida. Storage and handling instructions and a barcode are also visible.*
FDA Label Image

Lbl5-80mg30s.jpg (Lbl5 80mg30s)

Lbl5-80mg30s.jpg (Lbl5 80mg30s)
A packaging label for Amlodipine and Atorvastatin Tablets, USP, containing 30 film-coated tablets. The strength shown is 5 mg amlodipine and 80 mg atorvastatin. Label includes storage instructions, dosage note referencing package insert, and manufacturer information for Apotex Corp., Toronto, Ontario, and Apotex Inc., Weston, Florida. Barcode and NDC 60505-3492-3 are visible.*
FDA Label Image

Figure 1 (Amlodipine Besylate And Atorvastatin Calcium 02)

Figure 1 (Amlodipine Besylate And Atorvastatin Calcium 02)
A Kaplan-Meier survival curve chart comparing event rates over 24 months between two groups labeled Placebo and Amlodipine. The vertical axis represents the event rate ranging from 0.0 to 0.25, and the horizontal axis shows time in months from 0 to 24. The chart includes a hazard ratio of 0.691 with a 95% confidence interval (0.54, 0.88) and a p-value of 0.003, indicating statistical analysis of outcomes between groups.*
FDA Label Image

Figure 2 (Amlodipine Besylate And Atorvastatin Calcium 03)

Figure 2 (Amlodipine Besylate And Atorvastatin Calcium 03)
A forest plot displaying hazard ratios with 95% confidence intervals comparing Amlodipine to placebo across various patient subgroups, including overall population, age groups, gender, baseline sitting systolic blood pressure, baseline vessel disease, vessel stenosis status, and PCI-stent strata. The horizontal axis represents the hazard ratio scale from 0 to 2, with markers indicating favor towards Amlodipine or placebo.*
FDA Label Image

Figure 3 (Amlodipine Besylate And Atorvastatin Calcium 04)

Figure 3 (Amlodipine Besylate And Atorvastatin Calcium 04)
A cumulative incidence line graph comparing Atorvastatin to Placebo over a period of 3.5 years. The y-axis shows cumulative incidence in percentage, and the x-axis indicates time in years. The graph includes a hazard ratio (HR) value with confidence interval and a p-value.*
FDA Label Image

Figure 4 (Amlodipine Besylate And Atorvastatin Calcium 05)

Figure 4 (Amlodipine Besylate And Atorvastatin Calcium 05)
A line graph showing cumulative hazard percentage on the y-axis against time in years to first primary endpoint through four years of follow-up on the x-axis. Two lines compare placebo (dashed) and atorvastatin (solid), indicating lower cumulative hazard for atorvastatin with a hazard ratio of 0.63 (0.48-0.83), p=0.001.*
FDA Label Image

Figure 5 (Amlodipine Besylate And Atorvastatin Calcium 06)

Figure 5 (Amlodipine Besylate And Atorvastatin Calcium 06)
A line graph depicting the percentage of subjects experiencing a cardiovascular event over time (up to 5 years). Two lines compare atorvastatin doses: 10 mg (dashed line) and 80 mg (solid line). The graph shows time to first major cardiovascular endpoint with a hazard ratio (HR) of 0.78 and p-value of 0.0002, indicating statistical comparison between doses.*
FDA Label Image

Amlodipine (Amlodipine)

Amlodipine (Amlodipine)
Chemical structure of the active ingredients Amlodipine and Atorvastatin, showing molecular components including rings and functional groups consistent with their chemical formulas.*
FDA Label Image

Atorvastatin-glycol-solvate (Atorvastatin Glycol Solvate)

Atorvastatin-glycol-solvate (Atorvastatin Glycol Solvate)
Chemical structure diagram of the active ingredient Atorvastatin calcium, showing its molecular components including calcium ions and associated organic groups.*

* 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.