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WEGOVY

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
WEGOVY
Generic name
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
4
NDC product codes
4
Packages
5
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Semaglutide 1.5 mg/1 2200644 View
Semaglutide 25 mg/1 2200644 View
Semaglutide 4 mg/1 2200644 View
Semaglutide 9 mg/1 2200644 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
9

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
218316
Application type
NDA · New Drug Application
Approval date
December 22, 2025
Sponsor
NOVO
Products on application
4
Submissions recorded
6
Products approved under application 218316.
Product Trade name Form Strength Ingredient Status TE Flags
218316-001 WEGOVY TABLET SEMAGLUTIDE Prescription — RLD RS
218316-002 WEGOVY TABLET SEMAGLUTIDE Prescription — RLD RS
218316-003 WEGOVY TABLET SEMAGLUTIDE Prescription — RLD RS
218316-004 WEGOVY 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 February 4, 2026
8536122 March 20, 2026 002 Yes February 4, 2026
8536122 March 20, 2026 003 Yes February 4, 2026
8536122 March 20, 2026 004 Yes February 4, 2026
8129343 December 5, 2031 001 Yes February 4, 2026
8129343 December 5, 2031 002 Yes February 4, 2026
8129343 December 5, 2031 003 Yes February 4, 2026
8129343 December 5, 2031 004 Yes February 4, 2026
11382957 December 16, 2031 001 No January 16, 2026
11382957 December 16, 2031 002 No January 16, 2026
9278123 December 16, 2031 003 No U-4389 February 5, 2026
11382957 December 16, 2031 003 No January 16, 2026
9278123 December 16, 2031 004 No U-4389 January 16, 2026
11382957 December 16, 2031 004 No January 16, 2026
11033499 June 19, 2033 001 No U-4496 May 7, 2026
11033499 June 19, 2033 002 No U-4496 May 7, 2026
11033499 June 19, 2033 003 No U-4496 May 7, 2026
11033499 June 19, 2033 004 No U-4496 May 7, 2026
12239739 May 2, 2034 001 No U-4388 January 16, 2026
10278923 May 2, 2034 001 No U-4389 January 16, 2026
12239739 May 2, 2034 002 No U-4388 January 16, 2026
10278923 May 2, 2034 002 No U-4389 January 16, 2026
12239739 May 2, 2034 003 No U-4388 January 16, 2026
10278923 May 2, 2034 003 No U-4389 January 16, 2026
12239739 May 2, 2034 004 No U-4388 January 16, 2026
10278923 May 2, 2034 004 No U-4389 January 16, 2026
12396953 February 1, 2039 001 No U-4387 January 16, 2026
11833248 February 1, 2039 001 No U-4387 January 16, 2026
12396953 February 1, 2039 002 No U-4387 January 16, 2026
11833248 February 1, 2039 002 No U-4387 January 16, 2026
12396953 February 1, 2039 003 No U-4387 January 16, 2026
11833248 February 1, 2039 003 No U-4387 January 16, 2026
12396953 February 1, 2039 004 No U-4387 January 16, 2026
11833248 February 1, 2039 004 No U-4387 January 16, 2026
Regulatory exclusivity periods.
Code Expires Product
I-935 March 8, 2027 001
I-935 March 8, 2027 002
I-935 March 8, 2027 003
I-935 March 8, 2027 004
NP December 22, 2028 001
NP December 22, 2028 002
NP December 22, 2028 003
NP December 22, 2028 004

Approval history

Source: Drugs@FDA
Most recent submissions on application 218316.
Type No. Action Status Date Review
Supplement 7 Labeling Approved June 18, 2026 Standard
Supplement 3 Labeling Approved May 5, 2026 Standard
Supplement 5 Labeling Approved March 19, 2026 Standard
Supplement 4 Labeling Approved February 25, 2026 Standard
Supplement 2 Labeling Approved January 29, 2026 Standard
Original application 1 Type 3 - New Dosage Form Approved December 22, 2025 Standard

Review documents

  • 0 · Original application · September 21, 2026
  • 0 · Original application · September 8, 2026
  • 0 · Supplement · June 23, 2026
  • 0 · Supplement · May 12, 2026
  • 0 · Supplement · March 24, 2026
  • 0 · Supplement · March 24, 2026
  • 0 · Supplement · March 23, 2026
  • 0 · Supplement · March 2, 2026
  • 0 · Supplement · February 27, 2026
  • 0 · Supplement · February 5, 2026
  • 0 · Supplement · January 30, 2026
  • 0 · Original application · December 23, 2025

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.

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
0169-4404-31 0169-4404 Novo Nordisk Pharmaceutical Industries, LP 30 TABLET in 1 BOTTLE, PLASTIC (0169-4404-31) January 6, 2026
0169-4409-31 0169-4409 Novo Nordisk Pharmaceutical Industries, LP 30 TABLET in 1 BOTTLE, PLASTIC (0169-4409-31) January 6, 2026
0169-4415-31 0169-4415 Novo Nordisk Pharmaceutical Industries, LP 30 TABLET in 1 BOTTLE, PLASTIC (0169-4415-31) January 6, 2026
0169-4415-92 0169-4415 Novo Nordisk Pharmaceutical Industries, LP 30 TABLET in 1 BOTTLE, PLASTIC (0169-4415-92) January 6, 2026
0169-4425-31 0169-4425 Novo Nordisk Pharmaceutical Industries, LP 30 TABLET in 1 BOTTLE, PLASTIC (0169-4425-31) January 6, 2026
0169-4404 0169-4404 Novo Nordisk Pharmaceutical Industries, LP — January 6, 2026
0169-4409 0169-4409 Novo Nordisk Pharmaceutical Industries, LP — January 6, 2026
0169-4415 0169-4415 Novo Nordisk Pharmaceutical Industries, LP — January 6, 2026
0169-4425 0169-4425 Novo Nordisk Pharmaceutical Industries, LP — January 6, 2026

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

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