(Questions regarding this file should be sent to firstname.lastname@example.org)
With the exception of the billing unit data in the NSDE document, this file is generated from SPL documents sent to FDA for inclusion in the FDA Online Label Repository at labels.fda.gov. The information in the SPL documents is for products in final marketed form. The report is updated each business day.
Inclusion of information in the NSDE does not indicate that FDA has verified the information provided. The content of the information is the responsibility of the author of the SPL document. The author is designated in the SPL document and may be either a manufacturer, including a repackager or relabeler, or, for products subject to private labeling arrangements, the entity under whose own label or trade name the product will be distributed.
Assignment of a National Drug Code (NDC) or National Health Related Item Code (NHRIC) does not in any way denote FDA approval of the product. Any representation that creates an impression of official approval because of possession of an NDC or NHRIC number is misleading and constitutes misbranding.
Neither inclusion in the NSDE nor possession of an NDC number is a determination that a product is a drug as defined by the FD&C Act, nor does either denote that a product is covered or eligible for reimbursement by Medicare, Medicaid or other payers.
Questions regarding this file should be sent to email@example.com
Data Elements and their definitions:
This column includes three segments National Drug Codes (NDC), two or three segment National Health Related Item Codes (NHRIC) or the facility and product description International Society of Blood Transfusion codes (ISBT).
The NDC11 is a transformed version of the segmented NDC code using the algorithm defined by the National Council for Prescription Drug Programs (NCPDP). Three segment NHRIC codes have also been transformed following the same algorithm. Two segment NHRIC and ISBT codes have not been transformed.
Also known as the trade name. It is the name of the product chosen by the author.
This column contains the dosage form as manufactured.
The author chooses a category that most closely describes the FDA regulations for marketing the product.
Application Number or citation
Some types of marketing categories may be associated with FDA assigned numbers (e.g., NDA123456) or regulatory citations (e.g., part348).
The author chooses a type that most closely describes the product (e.g., Vaccine) associated with the SPL document.
Marketing Start Date
This is the date the author indicates when it started marketing the packaged product.
Marketing End Date
This is the expiration date of the last lot distributed. Products that are actively being marketed will not have a marketing end date. Products that are no longer manufactured may have a future end marketing date for the expiration of the last lot distributed.
The National Council for Prescription Drug Programs (NCPDP) developed the Billing Unit Standard to assist in consistent and accurate billing of pharmaceutical products. Information on the NCPDP Billing Unit Standard may be found at http://www.ncpdp.org/PDF/BUS_overview.pdf. This column may contain a NCPDP Billing Unit (GM, ML or EA).