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UBRELVY

ubrogepant · 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.

Overview

Brand name
UBRELVY
Generic name
ubrogepant
Dosage form
Tablet
Route
Oral
Marketing category
NDA · NDA
Labeler
Allergan, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
9
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
Ubrogepant 100 mg/1 — —
Ubrogepant 50 mg/1 — —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet
Route of administration
Oral
Presentations
11

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
Calcitonin Gene-related Peptide Receptor Antagonist [EPC] EPC 4 members — no class page
Calcitonin Gene-related Peptide Receptor Antagonists [MoA] MoA 4 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
211765
Application type
NDA · New Drug Application
Approval date
December 23, 2019
Sponsor
ABBVIE
Products on application
2
Submissions recorded
5
Products approved under application 211765.
Product Trade name Form Strength Ingredient Status TE Flags
211765-001 UBRELVY TABLET UBROGEPANT Prescription — RLD
211765-002 UBRELVY TABLET UBROGEPANT 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
9499545 November 10, 2031 001 Yes U-2718 January 21, 2020
9833448 November 10, 2031 001 No U-2718 January 21, 2020
9833448 November 10, 2031 002 No U-2718 January 21, 2020
9499545 November 10, 2031 002 Yes U-2718 January 21, 2020
8754096 July 19, 2032 001 Yes U-2717 January 21, 2020
8754096 July 19, 2032 002 Yes U-2717 January 21, 2020
8912210 December 23, 2033 001 Yes January 21, 2020
8912210 December 23, 2033 002 Yes January 21, 2020
12220408 January 30, 2035 001 No March 12, 2025
12458632 January 30, 2035 001 No November 4, 2025
11925709 January 30, 2035 001 No April 10, 2024
12168004 January 30, 2035 001 No January 15, 2025
10117836 January 30, 2035 001 No January 21, 2020
12310953 January 30, 2035 001 No June 25, 2025
12458633 January 30, 2035 001 No November 4, 2025
12220408 January 30, 2035 002 No March 12, 2025
12168004 January 30, 2035 002 No January 15, 2025
12458633 January 30, 2035 002 No November 4, 2025
10117836 January 30, 2035 002 No January 21, 2020
11925709 January 30, 2035 002 No April 10, 2024
12310953 January 30, 2035 002 No June 25, 2025
12458632 January 30, 2035 002 No November 4, 2025
11717515 December 22, 2041 001 No U-3677 September 7, 2023
12329750 December 22, 2041 001 No U-4213 July 16, 2025
12194030 December 22, 2041 001 No U-4121 February 11, 2025
12194030 December 22, 2041 001 No U-4122 February 11, 2025
11857542 December 22, 2041 001 No U-3786 January 31, 2024
12070450 December 22, 2041 002 No U-3992 September 25, 2024

Approval history

Source: Drugs@FDA
Most recent submissions on application 211765.
Type No. Action Status Date Review
Supplement 12 Labeling Approved June 5, 2025 Standard
Supplement 13 Labeling Approved March 21, 2025 Standard
Supplement 7 Labeling Approved February 17, 2023 Standard
Supplement 2 Labeling Approved March 3, 2021 Standard
Original application 1 Type 1 - New Molecular Entity Approved December 23, 2019 Standard

Review documents

  • 0 · Supplement · June 13, 2025
  • 0 · Supplement · June 6, 2025
  • 0 · Supplement · March 25, 2025
  • 0 · Supplement · March 24, 2025
  • 0 · Supplement · February 21, 2023
  • 0 · Supplement · February 17, 2023
  • 0 · Supplement · March 4, 2021
  • 0 · Original application · January 22, 2020
  • 0 · Original application · December 26, 2019
  • 0 · Original application · December 23, 2019

Adverse event reports

Source: openFDA FAERS
0
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.

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
0023-6498-01 0023-6498 Allergan, Inc. 1 PACKET in 1 BOX (0023-6498-01) / 1 TABLET in 1 PACKET December 23, 2019
0023-6498-04 0023-6498 Allergan, Inc. 4 PACKET in 1 BOX (0023-6498-04) / 1 TABLET in 1 PACKET December 23, 2019
0023-6498-10 0023-6498 Allergan, Inc. 10 PACKET in 1 BOX (0023-6498-10) / 1 TABLET in 1 PACKET (0023-6498-02) December 23, 2019
0023-6498-16 0023-6498 Allergan, Inc. 16 PACKET in 1 BOX (0023-6498-16) / 1 TABLET in 1 PACKET (0023-6498-02) December 23, 2019
0023-6498-30 0023-6498 Allergan, Inc. 30 PACKET in 1 BOX (0023-6498-30) / 1 TABLET in 1 PACKET (0023-6498-02) December 23, 2019
0023-6501-01 0023-6501 Allergan, Inc. 1 PACKET in 1 BOX (0023-6501-01) / 1 TABLET in 1 PACKET December 23, 2019
0023-6501-10 0023-6501 Allergan, Inc. 10 PACKET in 1 BOX (0023-6501-10) / 1 TABLET in 1 PACKET (0023-6501-02) December 23, 2019
0023-6501-16 0023-6501 Allergan, Inc. 16 PACKET in 1 BOX (0023-6501-16) / 1 TABLET in 1 PACKET (0023-6501-02) December 23, 2019
0023-6501-30 0023-6501 Allergan, Inc. 30 PACKET in 1 BOX (0023-6501-30) / 1 TABLET in 1 PACKET (0023-6501-02) December 23, 2019
0023-6498 0023-6498 Allergan, Inc. — December 23, 2019
0023-6501 0023-6501 Allergan, Inc. — December 23, 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

Generated September 25, 2026 · 10 sections on this page.