FDA database lists Rybelsus 14 mg tablet as to be discontinued
The FDA shortage database now lists Rybelsus 14 mg as to be discontinued, with no date for when supplies end or when the named replacement, Ozempic tablets, might arrive.
Rybelsus, the oral tablet form of semaglutide, has been posted to the FDA's drug shortage database as "To Be Discontinued," with a discontinuation date of June 4, 2026 [1]. The record states the product will be replaced by Ozempic (semaglutide) tablets [1].
The entry names the 14 mg tablet, package NDC 0169-4314-30, and lists Novo Nordisk Pharmaceutical Industries, LP as the manufacturer, with Novo Nordisk, Inc. listed as the company of record [1]. The status field reads "To Be Discontinued," the update type is "New," and both the initial posting date and the discontinuation date are June 4, 2026 [1]. The product appears under application number NDA213051 and the therapeutic category Endocrinology/Metabolism, with a dosage form of tablet and a route of oral [1]. A search of the same database for semaglutide returns three results in total [1]. The posting also lists a contact number, 833-493-4689 [1].
The reason recorded in the entry is: "Discontinuation of the manufacture of the drug. These products will be replaced by Ozempic (semaglutide) tablets." [1] The record does not say when current supplies are expected to run out, whether pharmacies can still fill existing prescriptions, or when an Ozempic tablet product would reach the market [1]. The database carries a standing disclaimer that its contents should be treated as unvalidated and should not be relied on to make decisions about medical care [1].
The entry that names a tablet strength identifies the 14 mg version [1]. Other strengths are not described in that record [1].
Why it matters for patients
Rybelsus is semaglutide taken as a daily tablet rather than as an injection [1]. A "to be discontinued" listing signals that the manufacturer intends to stop making the product, but this record does not give a date when supply actually ends [1]. That leaves the practical timing unclear for people who currently take the tablet.
The posting names only one replacement: Ozempic (semaglutide) tablets [1]. It does not state whether that product is approved, when it might be sold, what it would cost, or whether insurance would cover it [1]. The record also says nothing about refills, coverage for Rybelsus in the meantime, or how a prescriber would move a patient to a different product [1]. Those details have not been reported in this listing.
The database entry is a manufacturer notice about manufacturing status, not a safety notice or a recall [1]. It does not describe any safety issue with semaglutide tablets, and no reason beyond the discontinuation of manufacture is given [1].
What happens next
The discontinuation date on the posting is June 4, 2026, and the entry is marked as new as of that date [1]. The listing gives no timeline for when supplies run out, no launch date for the Ozempic tablets it names as a replacement, and no further FDA action [1]. Anyone looking for firm dates for the end of Rybelsus supply or the start of an oral Ozempic product will not find them in this record [1].
Sources
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