Isotretinoin Capsule
Product Images NDC 69238-1256

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 69238-1256). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amneal Pharmaceuticals Ny 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

Structural Formula (Isotretinoin Capsules Usp Absorica 1)

FDA Label Image

30mg Carton (Isotretinoin Capsules Usp Absorica 10)

30mg Carton (Isotretinoin Capsules Usp Absorica 10)
This document seems to be related to medication and provides information about isotretinoin capsules. It includes details such as dosage instructions, storage conditions, precautions, and guidelines for pharmacists dispensing the medication. The text also mentions the need for authorization from the IPLEDGE program before dispensing isotretinoin to registered patients. Additionally, it emphasizes not dispensing beyond a 30-day supply and preserving prescription packs intact. For more accurate details, further analysis may be required.*
FDA Label Image

35 mg Blister (Isotretinoin Capsules Usp Absorica 11)

35 mg Blister (Isotretinoin Capsules Usp Absorica 11)
This text contains important information regarding the use of Isotretinoin Capsules, USP for female patients. It highlights the serious birth defects that can occur and emphasizes the importance of not getting pregnant while taking this medication. The text provides details on the risks associated with pregnancy during Isotretinoin treatment, the need for multiple negative pregnancy tests, and the necessity of using effective birth control methods. It also mentions the severe birth defects that have been reported with isotretinoin use, including internal and external defects. The text warns female patients about the potential risks and emphasizes the need to read all the information provided by the doctor and pharmacist before starting treatment. It also discusses mental health concerns and suicide risks associated with isotretinoin use. Additionally, the text provides instructions on storage, important safety information, and common side effects to watch out for while taking Isotretinoin Capsules, USP.*
FDA Label Image

35mg Carton (Isotretinoin Capsules Usp Absorica 12)

35mg Carton (Isotretinoin Capsules Usp Absorica 12)
This text provides detailed storage instructions, reminders for pharmacists regarding dispensing isotretinoin capsules, and information about the medication. It includes the recommended storage temperature, protection from light, reminders to dispense only for registered patients under the iPLEDGE program, and details about the contents and dosage of isotretinoin capsules, USP. Pharmacists are reminded to dispense with the enclosed Medication Guide and not to dispense after a specified date.*
FDA Label Image

40 mg Blister (Isotretinoin Capsules Usp Absorica 13)

40 mg Blister (Isotretinoin Capsules Usp Absorica 13)
This is information related to the use of isotretinoin capsules, USP, specifically warning female patients about the risk of severe birth defects if taken during pregnancy. It emphasizes the importance of not getting pregnant while taking this medication and the need for using effective birth control methods. The text also provides guidance on what to do before, during, and after treatment with isotretinoin capsules, USP to prevent birth defects. It includes important instructions about how to take the medication correctly, what side effects to watch for, and when to contact a doctor. Additionally, the text addresses mental health concerns, such as depression, suicide risk, and other serious side effects that may occur while using isotretinoin capsules, USP. The information highlights the necessity for female patients to understand and follow specific guidelines to prevent pregnancy and ensure safe usage of the medication.*
FDA Label Image

40mg Carton (Isotretinoin Capsules Usp Absorica 14)

40mg Carton (Isotretinoin Capsules Usp Absorica 14)
This text provides information about Isotretinoin Capsules, USP. It mentions contraindications during pregnancy and advises pharmacists to dispense prescription packs intact. The dosage information can be found in the prescribing information. Additionally, it instructs to store the medication at specific temperatures and protect it from light. The text also includes instructions for pharmacists on how to dispense the medication to registered patients.*
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Figure 1 (Isotretinoin Capsules Usp Absorica 2)

Figure 1 (Isotretinoin Capsules Usp Absorica 2)
This text provides an overview of the Mean Lesion Count at different time points during a study on Isotretinoin Capsules. It lists the Baseline, Week 4, Week 8, and Week 12 visits for analysis purposes.*
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10 mg Blister (Isotretinoin Capsules Usp Absorica 3)

10 mg Blister (Isotretinoin Capsules Usp Absorica 3)
This is a detailed warning and information sheet related to Isotretinoin Capsules, USP, emphasizing the severe birth defects it can cause in pregnant women. The text stresses the importance of not getting pregnant while taking this medication and outlines specific precautions and steps that female patients must follow, such as undergoing pregnancy tests and using multiple forms of birth control. The document also warns about potential mental health side effects, including depression and suicidal thoughts, that can occur while taking this medication. Additionally, it provides guidance on storing the capsules, avoiding certain activities, and reporting any unusual symptoms to a doctor.*
FDA Label Image

10mg Carton (Isotretinoin Capsules Usp Absorica 4)

10mg Carton (Isotretinoin Capsules Usp Absorica 4)
This is a medication information sheet for Isotretinoin capsules, USP. It includes dosage instructions, reminders for pharmacists, storage conditions, and precautions such as protecting from light and contraindications in pregnancy. The text also mentions the importance of dispensing prescription packs intact and contacting the iPledge program for authorization before dispensing.*
FDA Label Image

20 mg Blister (Isotretinoin Capsules Usp Absorica 5)

20 mg Blister (Isotretinoin Capsules Usp Absorica 5)
This text contains important information regarding isotretinoin capsules, USP, which can cause severe birth defects. Female patients are warned not to get pregnant before, during, or after treatment with isotretinoin capsules. It is crucial for patients to read and understand the materials provided by their doctor, participate in the iPLEDGE system, and take necessary precautions to prevent pregnancy. Additionally, the text highlights potential serious side effects, the importance of mental health awareness, and instructions on how to take isotretinoin capsules correctly. It also emphasizes the need for effective birth control and regular monitoring during treatment.*
FDA Label Image

20mg Carton (Isotretinoin Capsules Usp Absorica 6)

20mg Carton (Isotretinoin Capsules Usp Absorica 6)
This document provides important information about the medication Isotretinoin Capsules, USP, a treatment for various skin conditions. It includes guidance for pharmacists on dispensing the prescription packs intact, storing the capsules at the correct temperature range, and specific dosage instructions. Furthermore, precautions and restrictions, such as contraindications during pregnancy, are highlighted. It also mentions The PLEDGE program for registered patients and emphasizes not dispensing more than a 30-day supply.*
FDA Label Image

25 mg Blister (Isotretinoin Capsules Usp Absorica 7)

25 mg Blister (Isotretinoin Capsules Usp Absorica 7)
This is a detailed information leaflet regarding the use of Isotretinoin Capsules, USP, focusing on its potential to cause severe birth defects and the importance of avoiding pregnancy while taking the medication. The leaflet provides warnings, instructions, and precautions for female patients. It includes guidance on birth control measures, medication administration, potential side effects, and the necessity to consult healthcare professionals for any concerns. The document also addresses mental health considerations, such as the risk of depression or suicidal thoughts associated with isotretinoin use, and emphasizes the need to seek medical help in case of specific symptoms. Overall, it serves as a comprehensive resource for patients prescribed Isotretinoin Capsules, USP, ensuring they are well-informed and aware of the associated risks and precautions.*
FDA Label Image

25mg Carton (Isotretinoin Capsules Usp Absorica 8)

25mg Carton (Isotretinoin Capsules Usp Absorica 8)
This document provides important information on Isotretinoin Capsules, USP, including storage conditions (20° to 25°C with excursions permitted between 15° to 30°C), protection from light, contraindications in pregnancy, and guidelines for pharmacists on dispensing the medication. It also mentions the requirement to dispense only to registered patients after obtaining authorization from the iPLEDGE program. The medication guide is included in each prescription pack. It emphasizes the importance of dispensing intact packs and not exceeding a 30-day supply.*
FDA Label Image

30 mg Blister (Isotretinoin Capsules Usp Absorica 9)

30 mg Blister (Isotretinoin Capsules Usp Absorica 9)
This is a detailed medication warning regarding Isotretinoin Capsules, USP, emphasizing the severe birth defects it can cause if taken during pregnancy. It contains critical information for female patients regarding pregnancy prevention, including the necessity for two separate forms of birth control, negative pregnancy tests, and monthly tests during treatment. It also warns about the risks of mental health issues and suicide, as well as other potential serious side effects. The text instructs patients on how to properly take Isotretinoin, what to watch for, and the importance of interacting with the iPLEDGE system for program requirements.*

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