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RYBELSUS

oral semaglutide · Tablet

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
RYBELSUS
Generic name
oral semaglutide
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
Novo Nordisk Pharmaceutical Industries, LP
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
4
Data completeness
55% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Semaglutide 14 mg/1 2200644 View
Semaglutide 3 mg/1 2200644 View
Semaglutide 7 mg/1 2200644 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
7

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
GLP-1 Receptor Agonist [EPC] EPC All 15 members
Glucagon-Like Peptide 1 [CS] CS All 12 members
Glucagon-like Peptide-1 (GLP-1) Agonists [MoA] MoA All 15 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
213051
Application type
NDA · New Drug Application
Approval date
September 20, 2019
Sponsor
NOVO
Products on application
6
Submissions recorded
13
Products approved under application 213051.
Product Trade name Form Strength Ingredient Status TE Flags
213051-001 RYBELSUS TABLET SEMAGLUTIDE Prescription — RLD RS
213051-002 RYBELSUS TABLET SEMAGLUTIDE Prescription — RLD RS
213051-003 RYBELSUS TABLET SEMAGLUTIDE Prescription — RLD RS
213051-004 OZEMPIC TABLET SEMAGLUTIDE Prescription — RLD RS
213051-005 OZEMPIC TABLET SEMAGLUTIDE Prescription — RLD RS
213051-006 OZEMPIC TABLET SEMAGLUTIDE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
8536122 March 20, 2026 001 Yes U-2628 October 15, 2019
8536122 March 20, 2026 002 Yes U-2628 October 15, 2019
8536122 March 20, 2026 003 Yes U-2628 October 15, 2019
8536122 March 20, 2026 004 Yes U-2628 May 6, 2025
8536122 March 20, 2026 005 Yes U-2628 May 6, 2025
8536122 March 20, 2026 006 Yes U-2628 May 6, 2025
8129343 December 5, 2031 001 Yes U-2628 October 15, 2019
8129343 December 5, 2031 002 Yes U-2628 October 15, 2019
8129343 December 5, 2031 003 Yes U-2628 October 15, 2019
8129343 December 5, 2031 004 Yes U-2628 May 6, 2025
8129343 December 5, 2031 005 Yes U-2628 May 6, 2025
8129343 December 5, 2031 006 Yes U-2628 May 6, 2025
9278123 December 16, 2031 001 No U-2628 October 15, 2019
10960052 December 16, 2031 001 No April 26, 2021
10086047 December 16, 2031 001 No October 15, 2019
11382957 December 16, 2031 001 No July 26, 2022
9278123 December 16, 2031 002 No U-2628 October 15, 2019
10960052 December 16, 2031 002 No April 26, 2021
11382957 December 16, 2031 002 No July 26, 2022
10086047 December 16, 2031 002 No October 15, 2019
9278123 December 16, 2031 003 No U-2628 October 15, 2019
10960052 December 16, 2031 003 No April 26, 2021
11382957 December 16, 2031 003 No July 26, 2022
10086047 December 16, 2031 003 No October 15, 2019
11382957 December 16, 2031 004 Yes February 21, 2025
11382957 December 16, 2031 005 Yes February 21, 2025
9278123 December 16, 2031 006 Yes U-2628 February 21, 2025
11382957 December 16, 2031 006 Yes February 21, 2025
11759503 March 15, 2033 001 No October 12, 2023
10933120 March 15, 2033 001 No March 31, 2021
11759501 March 15, 2033 001 No October 12, 2023
11759502 March 15, 2033 001 No October 12, 2023
12594326 March 15, 2033 001 No April 20, 2026
10933120 March 15, 2033 002 No March 31, 2021
11759503 March 15, 2033 002 No October 12, 2023
12594326 March 15, 2033 002 No April 20, 2026
11759502 March 15, 2033 002 No October 12, 2023
11759501 March 15, 2033 002 No October 12, 2023
11759501 March 15, 2033 003 No October 12, 2023
11759502 March 15, 2033 003 No October 12, 2023
11759503 March 15, 2033 003 No October 12, 2023
10933120 March 15, 2033 003 No March 31, 2021
12594326 March 15, 2033 003 No April 20, 2026
11033499 June 19, 2033 001 No U-2628 May 7, 2026
11033499 June 19, 2033 002 No U-2628 May 7, 2026
11033499 June 19, 2033 003 No U-2628 May 7, 2026
11033499 June 19, 2033 004 No U-2628 May 7, 2026
11033499 June 19, 2033 005 No U-2628 May 7, 2026
11033499 June 19, 2033 006 No U-2628 May 7, 2026
10278923 May 2, 2034 001 No U-2628 October 15, 2019
12514822 May 2, 2034 001 No U-2628 January 14, 2026
12239739 May 2, 2034 001 Yes U-2628 May 6, 2025
10278923 May 2, 2034 002 No U-2628 October 15, 2019
12514822 May 2, 2034 002 No U-2628 January 14, 2026
12239739 May 2, 2034 002 Yes U-2628 May 6, 2025
10278923 May 2, 2034 003 No U-2628 October 15, 2019
12514822 May 2, 2034 003 No U-2628 January 14, 2026
12239739 May 2, 2034 003 Yes U-2628 May 6, 2025
12514822 May 2, 2034 004 No U-2628 January 14, 2026
12239739 May 2, 2034 004 Yes U-2628 May 6, 2025
10278923 May 2, 2034 004 Yes U-2628 February 21, 2025
12514822 May 2, 2034 005 No U-2628 January 14, 2026
12239739 May 2, 2034 005 Yes U-2628 May 6, 2025
10278923 May 2, 2034 005 Yes U-2628 February 21, 2025
12514822 May 2, 2034 006 No U-2628 January 14, 2026
12239739 May 2, 2034 006 Yes U-2628 May 6, 2025
10278923 May 2, 2034 006 Yes U-2628 February 21, 2025
11833248 February 1, 2039 004 No U-2628 January 7, 2025
12396953 February 1, 2039 004 No U-2628 September 3, 2025
11833248 February 1, 2039 005 No U-2628 January 7, 2025
12396953 February 1, 2039 005 No U-2628 September 3, 2025
11833248 February 1, 2039 006 No U-2628 January 7, 2025
12396953 February 1, 2039 006 No U-2628 September 3, 2025
Regulatory exclusivity periods.
Code Expires Product
I-976 October 17, 2028 001
I-976 October 17, 2028 002
I-976 October 17, 2028 003
I-976 October 17, 2028 004
I-976 October 17, 2028 005
I-976 October 17, 2028 006

Approval history

Source: Drugs@FDA
Most recent submissions on application 213051.
Type No. Action Status Date Review
Supplement 30 Labeling Approved January 30, 2026 Standard
Supplement 29 Labeling Approved October 17, 2025 Standard
Supplement 28 Labeling Approved October 17, 2025 Standard
Supplement 24 Efficacy Approved October 17, 2025 Standard
Supplement 21 Labeling Approved December 9, 2024 Standard
Supplement 20 Efficacy Approved December 9, 2024 Standard
Supplement 23 Labeling Approved November 1, 2024 901 Required
Supplement 18 Labeling Approved January 24, 2024 Standard
Supplement 12 Labeling Approved January 12, 2023 Standard
Supplement 11 Labeling Approved June 10, 2022 901 Required
Supplement 6 Manufacturing (CMC) Approved April 30, 2021 N/A
Supplement 1 Labeling Approved January 16, 2020 Standard
Original application 1 Type 3 - New Dosage Form Approved September 20, 2019 Priority

Review documents

  • 0 · Supplement · July 31, 2026
  • 0 · Supplement · February 3, 2026
  • 0 · Supplement · October 21, 2025
  • 0 · Supplement · October 21, 2025
  • 0 · Supplement · October 21, 2025
  • 0 · Supplement · October 21, 2025
  • 0 · Supplement · October 20, 2025
  • 0 · Supplement · October 20, 2025
  • 0 · Supplement · October 20, 2025
  • 0 · Supplement · October 20, 2025
  • 0 · Supplement · February 11, 2025
  • 0 · Supplement · February 11, 2025
  • 0 · Supplement · December 10, 2024
  • 0 · Supplement · December 10, 2024
  • 0 · Supplement · November 5, 2024
  • 0 · Supplement · November 5, 2024
  • 0 · Supplement · January 25, 2024
  • 0 · Supplement · January 25, 2024
  • 0 · Supplement · January 13, 2023
  • 0 · Supplement · January 13, 2023
  • 0 · Supplement · June 14, 2022
  • 0 · Supplement · June 14, 2022
  • 0 · Supplement · May 5, 2021
  • 0 · Original application · June 10, 2020
  • 0 · Supplement · January 17, 2020
  • 0 · Supplement · January 17, 2020
  • 0 · Original application · September 24, 2019
  • 0 · Original application · September 20, 2019

Adverse event reports

Source: openFDA FAERS
73,001
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: SEMAGLUTIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Shortages

Source: FDA Drug Shortages
Availability records from the FDA Drug Shortages database.
Status Availability Company Presentation Updated
To Be Discontinued Novo Nordisk, Inc. Rybelsus, Tablet, 14 mg (NDC 0169-4314-30) June 4, 2026
To Be Discontinued Novo Nordisk, Inc. Rybelsus, Tablet, 7 mg (NDC 0169-4307-30) June 4, 2026
To Be Discontinued Novo Nordisk, Inc. Rybelsus, Tablet, 3 mg (NDC 0169-4303-30) June 4, 2026

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0169-4303-30 0169-4303 Novo Nordisk Pharmaceutical Industries, LP 30 TABLET in 1 BOTTLE, PLASTIC (0169-4303-30) October 4, 2021
0169-4303-99 0169-4303 Novo Nordisk Pharmaceutical Industries, LP 30 TABLET in 1 BOTTLE, PLASTIC (0169-4303-99) October 4, 2021
0169-4307-30 0169-4307 Novo Nordisk Pharmaceutical Industries, LP 30 TABLET in 1 BOTTLE, PLASTIC (0169-4307-30) October 4, 2021
0169-4314-30 0169-4314 Novo Nordisk Pharmaceutical Industries, LP 30 TABLET in 1 BOTTLE, PLASTIC (0169-4314-30) October 4, 2021
0169-4303 0169-4303 Novo Nordisk Pharmaceutical Industries, LP — September 20, 2019
0169-4307 0169-4307 Novo Nordisk Pharmaceutical Industries, LP — September 20, 2019
0169-4314 0169-4314 Novo Nordisk Pharmaceutical Industries, LP — September 20, 2019

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts
Drug Shortages FDA Supply availability

Generated September 25, 2026 · 12 sections on this page.