Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate Tablet
Product Images NDC 0054-0189

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This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate (NDC 0054-0189). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hikma 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

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This is a medication with 216mg of buprenorphine HC, USP and 061mg of naloxone HCl dihydrate, USP, typically used sublingually. Each tablet is equivalent to 2mg of buprenorphine base and 0.5mg of naloxone base. The medication should be kept out of reach of children and stored between 20°1025°C (68°t0 77°F) at USP Controlled Room Temperature. The usual dosage should be followed as per the package insert for complete prescribing information. The medication should be dispensed with the attached medication guide by a pharmacist who distributed it via Hikma Pharmaceuticals USA Inc. In case of accidental consumption by children, emergency medical care may be needed.*
FDA Label Image

Image 02

FDA Label Image

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This is a description of Buprenorphine and Naloxone Sublingual Tablets, USP. Each tablet contains 8.64mg of buprenorphine HCl, equivalent to 8mg of buprenorphine base, and 2.44mg of naloxone HCI, equivalent to 7mg of naloxone base. The usual dosage is not given, and it is advised to check the package insert for complete prescribing information. The medication should be stored between 20°C and 25°C. The tablets come in a package of 30 and should be kept away from children. There is also a note for the pharmacist to dispense with the attached Medication Guide. The tablets are distributed by Hikma Pharmaceuticals US Inc in Berkeley Heights, NJ.*

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