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Posted: November 27, 2019

NLM Flagging SPLs Associated With Inactivated NDCs

In October 2019, NLM added an Indexing File (FDA-INITIATED COMPLIANCE ACTION - DRUG LISTING INACTIVATION) that includes NDCs from outdated or uncertified FDA listing records. NLM is now flagging SPLs associated with inactivated NDCs in DailyMed. Such SPLs will have a “Contains inactivated NDC Code(s)” link above the NDCs at the top of an SPL. Clicking on the link will display all the NDCs associated with the labeling, with the inactivated NDCs tagged. This tag will be removed after the manufacture takes action to be in compliance with the FDA.

A new link “View all NDC Code(s)” has also been added on the side and bottom, under More Info For This Drug.

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DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts). This Web site provides a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling found in medication package inserts.

The National Library of Medicine (NLM) provides this as a public service and does not accept advertisements. The drug labeling information on this Web site is the most recent submitted to the Food and Drug Administration (FDA) and currently in use; it may include, for example, strengthened warnings undergoing FDA review or minor editorial changes. These labels have been reformatted to make them easier to read.