Isotretinoin Capsule
Product Images NDC 70710-1575

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Isotretinoin (NDC 70710-1575). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Pharmaceuticals Usa 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

Image (A5b78223 8bce 490b A83c E342c25c082a 01)

FDA Label Image

Image (A5b78223 8bce 490b A83c E342c25c082a 02)

Image (A5b78223 8bce 490b A83c E342c25c082a 02)
This text appears to be a table or graph displaying the mean lesion count of patients taking isotretinoin capsules at different time points (baseline, week 4, week 8, week 12, week 16, and week 20). The data may be part of a clinical study or research report evaluating the efficacy of isotretinoin for treating certain skin conditions.*
FDA Label Image

10 mg (A5b78223 8bce 490b A83c E342c25c082a 03)

10 mg (A5b78223 8bce 490b A83c E342c25c082a 03)
This text is about a medication containing Isotretinoin USP in capsule form. It provides information on dosage, storage conditions, contraindications, and instructions for pharmacists on dispensing the medication. It also emphasizes the importance of keeping the drug away from children, protecting it from light, and provides a reference to a medication guide for additional details. Additionally, it mentions that the product is distributed by Zydus Pharmaceuticals (USA) Inc. and manufactured by Zydus Lifesciences Ltd. in India.*
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10 mg (A5b78223 8bce 490b A83c E342c25c082a 04)

FDA Label Image

20 mg (A5b78223 8bce 490b A83c E342c25c082a 05)

20 mg (A5b78223 8bce 490b A83c E342c25c082a 05)
This text appears to be a detailed pharmaceutical leaflet or brochure providing information about Isotretinoin USP capsules. It includes details such as dosage, storage instructions, child-resistant packaging, and precautions for dispensing. It also mentions the manufacturer, distributor, and contact information for the medication. The text emphasizes the importance of dispensing the medication guide to each patient and following specific instructions provided for pharmacists regarding dispensing practices. Special guidelines for pharmacists include obtaining authorization from the iPLEDGE program before dispensing, limiting the supply to a 30-day dosage, and not removing Prescription Packs from the carton until dispensed. This information is crucial for healthcare professionals and patients using Isotretinoin capsules for treatment.*
FDA Label Image

20 mg (A5b78223 8bce 490b A83c E342c25c082a 06)

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25 mg (A5b78223 8bce 490b A83c E342c25c082a 07)

25 mg (A5b78223 8bce 490b A83c E342c25c082a 07)
This description provides information about a medication known as Isotretinoin Capsules USP, each containing 25 mg of Isotretinoin. The drug is contraindicated in pregnancy and should be dispensed intact in a blister pack complying with child-resistant packaging requirements. It should be stored at a temperature between 20°C to 25°C, away from light. Pharmacists are reminded to dispense Isotretinoin only to registered patients after obtaining authorization from the iPLEDGE program. Special instructions are provided for pharmacists such as not dispensing more than a 30-day supply, writing the Risk Management Authorization number on the prescription, and including the Medication Guide in each Prescription Pack. The text also emphasizes that Isotretinoin capsules are not substitutable with ABSORICA LD. The manufacturer is Zydus Lifesciences Ltd. in Ahmedabad, India, distributed by Zydus Pharmaceuticals (USA) Inc. in Pennington, NJ. The description includes contact details and warnings about dispensing the drug.*
FDA Label Image

25 mg (A5b78223 8bce 490b A83c E342c25c082a 08)

25 mg (A5b78223 8bce 490b A83c E342c25c082a 08)
Not available.*
FDA Label Image

30 mg (A5b78223 8bce 490b A83c E342c25c082a 09)

30 mg (A5b78223 8bce 490b A83c E342c25c082a 09)
The text provides detailed information about isotretinoin capsules, including dosage, storage conditions, safety precautions, dispensing guidelines, and manufacturer details. It emphasizes the importance of following the iPLEDGE program for dispensing the medication only to registered patients and includes instructions for pharmacists on proper dispensing practices. It also mentions the medication guide included in each prescription pack and warns against substitution with a different product such as ABSORICA LD. It further instructs pharmacists to ensure intact packaging and contains contact information for further assistance.*
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30 mg (A5b78223 8bce 490b A83c E342c25c082a 10)

FDA Label Image

35 mg (A5b78223 8bce 490b A83c E342c25c082a 11)

35 mg (A5b78223 8bce 490b A83c E342c25c082a 11)
This is a detailed medication label for Isotretinoin Capsules, containing 35 mg per capsule. The text includes dosage instructions, storage conditions, contraindications in pregnancy, distribution information, and reminders for pharmacists on dispensing. It also mentions the iPLEDGE program for dispensing authorization and provides contact information for further inquiries. Additionally, it is emphasized to protect the medication from light and keep it out of children's reach. The text highlights the importance of dispensing intact prescription packs and includes special instructions for pharmacists on dispensing procedures. The manufacturer and distributor details are provided along with relevant NDC numbers for tracking.*
FDA Label Image

35 mg (A5b78223 8bce 490b A83c E342c25c082a 12)

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40 mg (A5b78223 8bce 490b A83c E342c25c082a 13)

40 mg (A5b78223 8bce 490b A83c E342c25c082a 13)
This text appears to be a medication label containing important information for pharmacists and patients regarding the use of Isotretinoin capsules. It provides details about the dosage, storage instructions, contraindications, manufacturer, distribution, and how to dispense the medication safely. The medication guide is also mentioned, along with contact information for additional resources. All information is in English and well-detailed for proper handling of the medication.*
FDA Label Image

40 mg (A5b78223 8bce 490b A83c E342c25c082a 14)

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