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LABELER CODE NUMBER 067881-0501 这个编号的产品如何查询在FDA的信息

时间: 2008-09-18 08:24:47 作者: 来源: 字号:
LABELER CODE NUMBER 067881-0501
关于这个产品,我只是知道这个编号;
请问,如何知道这个产品是否被FDA检查和批准;
如何检索相关信息

搜索半天没有头绪,请战友指教。
您真会开玩笑

Labeler Code - The Labeler Code is assigned by the FDA to all firms required to register and/or list with the FDA, i.e., manufacturers, repackers/relabelers or private label distributors. (Refer to regulation 21 CFR, Part 207, for specific drug firm requirements. A copy of this regulation is provided in Annex A, of this booklet.) Labeler Codes are all numeric. Some Veterinary Firms (depending upon their FDA registration requirements, e.g. Medicated Feed Mills) receive the pseudo Labeler Code 1900. Firms required to register with the FDA, but not drug list their products, e.g., Analytical Labs receive the pseudo Labeler Code 1500. If a Labeler Code has not been assigned, leave the field blank and a code will be assigned

难道您认为”贴标企业编码“和" 产品本身"有什么关系不成?

“Labeler” means an entity or person that receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale and that has a labeler code from the federal Food and Drug Administration under 21 Code of Federal Regulations, 207.20 (1999).
大刀战友,感谢你的帮助。
毕竟业有所不精,还是希望就下面几个问题求教老师:
1-这个labeler code对企业有什么作用?
2-FDA网站上面,通过查询这个labeler code是否可以确认具体企业名称和企业在FDA注册的品种?


Search NDC:

Search by NDC Number by Labeler Code :

根据药品名查NDC号:

看看这个贴子对你有帮助:
业不精要多学习啊!!!
简而言之,接受处方药物的用于销售的批发商和重新包装商等个人和团体,需要得到FDA给予特定的数字号码,比如说你想开个药店,你得去工商局/药监局/卫生部备案吧,人家给你个号码,类似于注册登记号,便于将来有问题查询!!!
真心感谢楼上几位战友的热情帮助,但是在你们提供的连接里面不能查到这个号码的任何信息。还是不能解决问题啊?
可能性有2种:1.骗子;2.FDA网站数据还没有更新

对FDA数据库修改的指导.part1.rar (166.02k)

是否应该考虑另外的因素啊

What products are included in the NDC Directory?

The current edition of the NDC Directory is limited to prescription drugs and insulin products that have been manufactured, prepared, propagated, compounded, or processed by registered establishments for commercial distribution. The products have been listed in accordance with the Drug Listing Act and regulatory provisions concerning the submission of drug product information to FDA.

Why are some drug products not in the NDC Directory?

There are a number of reasons why a drug product may not appear in the NDC Directory, such as:

· the product may not be a prescription drug or an insulin product
· the firm has notified the FDA that the product is no longer being marketed;
· the firm has not complied fully with its listing obligations and therefore its product is not included until complete information is provided.

真是很逗啊,今天上去看,FDA换个脸:

(缩略图,点击图片链接看原图)
不是今天换脸的,昨天我上的时候已经换了脸了,呵呵
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