Otezla Kit
Product Images NDC 55513-508

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Otezla (NDC 55513-508). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amgen, 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

The Chemical Structure For Otezla Tablets Is Apremilast. Apremilast Is A Phosphodiesterase 4 (pde4) Inhibitor. Apremilast Is Known Chemically As N-[2-[(1s)-1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-2,3-dihydro-1,3-dioxo-1h-isoindol-4-yl]acetamide. Its Empirical Formula Is C22h24n2o7s And The Molecular Weight Is 460.5. (Otezla 01)

Chemical structure of apremilast, the active ingredient in Otezla, depicted as a 2D molecular diagram showing the arrangement of atoms and bonds within the molecule.*

FDA Label Image

Figure 1: Mean (± Se) Number Of Oral Ulcers By Time Point Through Week 12 (itt Population) (Otezla 02)

Line graph showing the proportion of subjects with whole body itch NRS response over 16 weeks comparing Otezla 30 mg twice daily and placebo. The vertical axis represents percentage response, and the horizontal axis represents time in weeks. The Otezla 30 mg group shows a higher and increasing proportion of subjects responding compared to placebo.*

FDA Label Image

Figure 2: Mean (± Se) Oral Ulcer Pain On A Visual Analog Scale By Time Point Through Week 12 (itt Population) (Otezla 03)

A line graph comparing the proportion of subjects with scalp itch NRS response (%) over 16 weeks between placebo and Otezla 30 mg twice daily. The graph shows higher response rates for Otezla than placebo throughout the study period, with time in weeks on the x-axis and response proportion on the y-axis.*

FDA Label Image

Pdp Image For 55513-137-28:ndc 55513-137-28rx Onlyotezla®(apremilast) Tabletsamgen®28 Tablets30 mg Per Tablet (Otezla 04)

A line graph comparing the mean number of oral ulcers over 12 weeks between placebo and OTEZLA 30 mg taken twice daily. The graph shows a decrease in oral ulcers for OTEZLA compared to placebo, with data points at multiple time intervals (0, 1, 2, 4, 6, 8, 10, and 12 weeks). Error bars indicate variability in the data.*

FDA Label Image

Pdp Image For 55513-137-60:ndc 55513-137-60otezla®(apremilast) Tablets30 mgrx Only60 Tabletspatent: Https://pat.amgen.com/otezlastore Below 30°c (86°f)dosage: The Recommended Doseis A 30 mg Tablet Taken By Mouthtwice Daily.see Full Prescribing Informationfor Dosing And Administration.otezla® Is Registered Trademarkof Amgen Inc.manufactured For:amgen Inc.thousand Oaks, Ca 91320-1799 U.s.a.amgen®©2014-2015, 2020 Amgen Inc.all Rights Reservned.made In Switzerland (Otezla 05)

A line chart comparing mean oral ulcer pain over 12 weeks between placebo and Otezla 30 mg twice daily. The y-axis represents mean oral ulcer pain, and the x-axis represents time in weeks. The Otezla treatment group shows a notable decrease in pain compared to the placebo group.*

FDA Label Image

Pdp Image For 55513-369-55:ndc 55513-369-55rx Onlyotezla®(apremilast) Tablets28 Daystarter Packthis Pack Contains The Followingfor Tritration Over 5 Days Up To Theprescribed Dose Of 30 mg:four (10 mg tabletsFour)

Otezla 30 mg tablets packaging label showing the brand name, generic name apremilast, and a count of 28 tablets. The label includes the Amgen logo, NDC 55513-137-28, and indicates the product is prescription only.*

FDA Label Image

Pdp Image For 55513-485-95:ndc 55513-485-95rx Onlyotezla®(apremilast) Tabletsstarter Packsample (NOT FOR SALEThis pack contains the followingfor titration over 5 days up to theprescribed dose of 30 mg:Four)

Otezla 30 mg tablets packaging label showing the brand name, generic name apremilast, and dosage strength of 30 mg. The label indicates a package containing 60 tablets, manufactured for Amgen Inc. Instructions include storing below 30°C and directions to see full prescribing information for dosage and administration. The label also features the Amgen logo and states the product is made in Switzerland.*

FDA Label Image

Pdp Image For 55513-485-96:ndc 55513-485-96rx Onlystarter Packsample (NOT FOR SALEEach pack contains the following for titration over5 days up to the prescribed dose of 30 mg:Four)

Otezla 30 mg (apremilast) tablets label, a prescription drug manufactured by Amgen, Inc. The label indicates 500 tablets in the package and instructs storage below 30°C (86°F). It includes directions to see full prescribing information for dosage and administration. The label also has the Amgen logo, barcode, and patent URL.*

FDA Label Image

Otezla 09

Otezla (apremilast) tablets 28 Day Starter Pack packaging label. The label shows it contains 55 tablets in various strengths for titration: 10 mg, 20 mg, and 30 mg tablets. The product is a prescription drug labeled by Amgen, Inc.*

FDA Label Image

Otezla 10

Otezla (apremilast) tablets Starter Pack kit by Amgen, Inc. The packaging indicates it is a sample starter pack for titration over 5 days up to the prescribed dose of 30 mg, containing 27 tablets: four 10 mg, four 20 mg, and nineteen 30 mg tablets. The label includes the NDC 55513-485-95 and states Rx Only.*

FDA Label Image

Otezla 11

Otezla Starter Pack sample packaging label for apremilast tablets from Amgen, Inc. The label specifies a titration pack containing 10 mg, 20 mg, and 30 mg tablets for a 5-day dosage escalation to 30 mg, with a total of 27 tablets in each pack. It is marked for prescription use and sample distribution only.*

* 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.