NDC 51808-103 I 123 Mibg Meta Iodobenzylguanidine

The NDC code 51808-103 is assigned by the FDA to the product I 123 Mibg Meta Iodobenzylguanidine which is product labeled by Anazaohealth Corporation. The product's dosage form is . The product is distributed in a single package with assigned NDC code 51808-103-01 1 injection, powder, lyophilized, for solution in 1 container . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

Iobenguane is indicated as a radioactive isotope diagnosing for adrenomedullary disorders and neuroendocrine tumors.Tumors, adrenal medulla (diagnosis): I-123 MIBG is used for diagnostic imaging of the adrenal medulla, for the evaluation and localization of intra- and extra-adrenal pheochromocytomas, paragangliomas, and neuroblastomas, as well as for localization of metastatic lesions from these tumors. I-123 MIBG can also be used for confirmation of diagnosis of pheochromocytoma when catecholamine determination tests are unclear.Tumors, carcinoid (diagnosis): I-123 MIBG scintigraphy is used as screening procedures for suspected carcinoid tumors, especially those of intestinal origin.Hyperplasia, adrenal medulla (diagnosis): I-123 MIBG is used in the evaluation of the adrenal medulla for disorders such as medullary hyperplasia in patients at risk of developing medullary disease (e.g., multiple endocrine neoplasia [MEN type 2, MEN type 3]).Carcinoma, thyroid (diagnosis): I-123 MIBG is used for diagnostic imaging of medullary thyroid carcinoma.DISTRIBUTIONAfter intravenous administration, there is rapid uptake of MIBG mainly in the liver, and in lesser amounts in the lungs, heart, and salivary glands. A limited number of patients may show activity in normal adrenals, lung, skeletal, muscle, and blocked thyroid glands. Although the uptake in normal adrenal glands is very low, hyperplastic adrenals and tumors such as pheochromocytoma, neuroblastoma, and other tumors with neurosecretory granules have a relatively higher uptake. Significant clearance of I-123 MIBG from the liver and the spleen occurs within 72 hours. I-123 MIBG—In adrenal medullary tumors: Initial images may be obtained 2 to 3 hours after injection. Images may also be obtained at 18 to 24 hours, and as late as 48 hours post injection. Most pheochromocytomas are visualized at 24 hours. However, due to the short half-life of I-123 MIBG, images may not be possible at times when background (e.g., liver) activity is low and imaging would be optimal. Small amounts of radioactivity used in diagnosis; radiation received is low and considered safe.ELIMINATIONRenal; about 40 to 50% of the injected activity is eliminated within 24 hours and about 70 to 90% within 4 days (mainly as unchanged drug with small amounts of I-123 m-iodohippuric acid [I-123 MIHA], I-123 iodide, and I-123 m-iodobenzoic acid [I-123 MIBA]).