The information in the SPL documents is for products in final marketed form..
All data in the NDC SPL Data Element (NSDE) file, with the exception of billing unit, 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.
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.