Chemical Structure (Chemical Structure)
Tofacitinib Tablet, Film Coated, Extended Release
Product Images NDC 70377-057
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 Tofacitinib (NDC 70377-057). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Biocon Pharma 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.
Figure-1 (Figure 1)
This document seems to contain information related to factors such as weight, age, gender, ethnicity, renal impairment level, hepatic impairment level, PK parameters (AuC, Cmax), and ratios with corresponding 90% confidence intervals. It appears to be data related to a study or evaluation of pharmacokinetics and clinical parameters in different populations and impairment conditions.*
Figure-2 (Figure 2)
This is a list of different drugs and their corresponding pharmacokinetic (PK) parameters such as AUC and Cmax when coadministered with other drugs or substrates including Methotrexate, Midazolam, Oral Contraceptives, Levonorgestrel, Metformin, and Ethinyl Estradiol. The table also includes the OCT & MATE Substrate AUC values for Metformin. The data indicates the ratio relative to a reference.*
Figure-3 (Figure 3)
Figure-4 (Figure 4)
Figure-5 (Figure 5)
Figure-6 (Figure 6)
Principal Display Panel (11 mg Tablet Bottle Label)
This text contains information related to the medication Tofacitinib in the form of Extended-Release Tablets. Each tablet contains 11 mg of Tofacitinib (equivalent to 17.764 mg Tofacitinib Citrate). It advises dispensing the Medication Guide to each patient. The storage conditions are specified to be between 20-25°C (68-77°F) with permitted excursions between 15-30°C (59-86°F). The package is child-resistant and not meant for repackaging. It provides details for consulting prescribing information and mentions the manufacturing details for Biocon Pharma Inc. in New Jersey, USA, and Biocon Pharma Limited in Bengaluru, India. Additionally, it includes batch serialization coding information and mentions the GTIN, SN, EXP, and LOT details.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
