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FDA Online Label Repository
The drug labels and other drug-specific information on this Web site represent the most recent drug listing information companies have submitted to the Food and Drug Administration (FDA). (See 21 CFR part 207.) The drug labeling and other information has been reformatted to make it easier to read but its content has neither been altered nor verified by FDA. The drug labeling on this Web site may not be the labeling on currently distributed products or identical to the labeling that is approved. Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies described in monographs. Drugs marked 'OTC monograph final' or OTC monograph not final' are not checked for conformance to the monograph. Drugs marked 'unapproved medical gas', 'unapproved homeopathic' or 'unapproved drug other' on this Web site have not been evaluated by FDA for safety and efficacy and their labeling has not been approved. In addition, FDA is not aware of scientific evidence to support homeopathy as effective.
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National Drug Code Directory
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The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. � 360)). Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily.
식품의약품안전처 의료기기 이상사례 간편표준코드집 상세
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의료기기 이상사례 간푠표준코드집(NCIT한글정의,NCIT영문정의,FDA출처코드,NCIT개념코드,FDA부분명)을 목록으로 조회
식품의약품안전처 의료기기 재평가공고
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재평가년도,재평가공고번호,재평가제목,제출방법,제출자료,공고일자,재평가코드명,업종,의료기기품목허가번호,품목명,허가일자,제조원국가,제조원,판매원국가,판매원,,제조(수입)업소,제조(수입)주소, 취소/취하구분,취소/취하일자 정보를 제공
식품의약품안전처 식품의약품안전평가원 생약 구성성분 정보
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분석번호, 화합물명, 분자식, 분자량, 구조식파일그룹번호, 약먕반호, 비고, 등록일시 정보를 제공
식품의약품안전처 의료기기 재평가 품목신청정보
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재평가일련번호,재평가공고번호,재평가제목,재평가년도,의료기기분류번호,등급,읭료기기품목일련번호,업허가일련번호,접수번호,관리청,업종,허가신고구분,의료기기품목허가번호,품목명,허가일자,제조원극가,제조원,판매원국가,판매원,제조(수입)업소명,제조(수입)주소,취소/취하구분,취소취하일자정보를 제공
식품의약품안전처 진단시약 품목별 포장단위정보
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품목일련번호, 업종구분, 허가신고구분, 품목허가번호, 품목명, 허가일자, 취소취하구분, 취소취하일자, 제품명, 포장단위명 정보를 제공
건강보험심사평가원 약가마스터 의약품주성분
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의약품 주성분(일반명) 현황에 대한 데이터셋 입니다. / 의약품주성분 코드, 성분명, 제형구분, 투여, 함량, 단위 등 정보를 제공합니다.