All oral formulations containing sodium bicarbonate including products. The risk or severity of adverse effects can be increased when Magnesium oxide is combined with Sodium fluorophosphate. A02AH Antacids with sodium bicarbonate No ATC 5th levels are assigned in this group. National Drug File Reference Terminology OID: 2.16.883.3.26.1. Magnesium oxide can cause a decrease in the absorption of Sodium feredetate resulting in a reduced serum concentration and potentially a decrease in efficacy. Source: The codes are from the National Drug File Reference Terminology (NDF-RT) maintained by the Department of Veterans Affairs. MAPP 7400.13: Determining the Established Pharmacologic Class for Use in the Highlights of Prescribing Information.Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information guidance.The list is regularly revised to ensure that the most up-to-date FDA EPC text phrases are available to the public.įor more information about how FDA determines the EPC for a drug product, see: To find the FDA EPC text phrase for an approved active moiety click on the “Highlights of Prescribing Information” heading on the Prescribing Information Resources website and then find the “FDA EPC Text Phrases for Indications and Usage Heading in Highlights” document. (Drug) is a (FDA EPC text phrase) indicated for. To express the DDD several abbreviations are used for units and routes of administration. For ordinary salt combinations in A02AD, fixed doses are used instead of individual doses for every single preparation (10 tablets. One exception, however, is antacids in combination with antispasmodics in A02AG, where the DDDs are based on treatment of ulcus. See also Guidelines: Part III D Principles for reviewing and changing DDD and Part V D Requests for changes to DDDs. The DDDs for antacids are based on treatment of hyperacidity and dyspepsia, not ulcus. The Physician Labeling Rule regulations require the following statement to appear under the Indications and Usage heading in the Highlights of Prescribing Information if a drug is a member of an EPC : The DDDs, which will be reviewed in 2023 (3 year revision), are listed here and in the annex I in the printed ATC Index. A02BD08: Pylera: caps: bismuth subcitrate 0.14 g/ tetracycline 0.125 g/ metronidazole 0.125 g: 12 UD (12 caps) A03AX58: Meteospasmyl: caps: alverine 60 mg/ simethicone 0.3 g: 2 UD (2 caps) A04AA55: Akynzeo : caps: palonosetron 0.5 mg/ netupitant 300 mg: 1 UD (1. Pharmacologic class is a group of active moieties that share scientifically documented properties and is defined on the basis of any combination of three attributes of the active moiety:Īn FDA “Established Pharmacologic Class” (EPC) text phrase is a pharmacologic class associated with an approved indication of an active moiety that the FDA has determined to be scientifically valid and clinically meaningful. ATC Code Brand name Dosage form Active ingredients per unit dose (UD) DDD comb.
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