Tromethamine Injection, Solution
NDC 0264-8031

The NDC code 0264-8031 is assigned by the FDA to the product Tromethamine. This pharmaceutical product is labeled by B. Braun Medical Inc. and is currently categorized as listed product. The medication is a injection, solution administered via intravenous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0264-8031-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

Tromethamine Injection is indicated for the prevention and correction of metabolic acidosis. In the following conditions it may help to sustain vital functions and thus provide time for treatment of the primary disease:Metabolic Acidosis Associated with Cardiac Bypass Surgery.Tromethamine Injection has been found to be primarily beneficial in correcting metabolic acidosis which may occur during or immediately following cardiac bypass surgical procedures.Correction of Acidity of ACD Blood in Cardiac Bypass Surgery.It is well known that ACD blood is acidic and becomes more acidic on storage. Tromethamine effectively corrects this acidity. Tromethamine Injection may be added directly to the blood used to prime the pump-oxygenator. When ACD blood is brought to a normal pH range the patient is spared an initial acid load. Additional tromethamine may be indicated during cardiac bypass surgery should metabolic acidosis appear.Metabolic Acidosis Associated with Cardiac Arrest.Acidosis is nearly always one of the consequences of cardiac arrest and, in some instances, may even be a causative factor in arrest. It is important therefore, that the correction of acidosis should be started promptly with other resuscitative efforts. By correcting acidosis, Tromethamine Injection has caused the arrested heart to respond to resuscitative efforts after standard methods alone had failed. In these cases, tromethamine was given intraventricularly. It is to be noted, however, that such precariously ill patients often have died subsequently of causes unrelated to the administration of tromethamine. With administration by the peripheral venous route, metabolic acidosis has been corrected in a majority of patients. The success in reinstitution of cardiac rhythm by this means probably has not been of the same order of magnitude as with the intraventricular route.

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

• TROMETHAMINE 3.6 g/100mL - An organic amine proton acceptor. It is used in the synthesis of surface-active agents and pharmaceuticals; as an emulsifying agent for cosmetic creams and lotions, mineral oil and paraffin wax emulsions, as a biological buffer, and used as an alkalizer. (From Merck, 11th ed; Martindale, The Extra Pharmacopoeia, 30th ed, p1424)

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

• RxCUI: 198412 - THAM 36 MG/ML in 500 ML Injection
• RxCUI: 198412 - 500 ML tromethamine 36 MG/ML Injection
• RxCUI: 198412 - tromethamine 18 GM per 500 ML Injection
• RxCUI: 198412 - tromethamine 3.6 GM per 100 ML Injection