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Neupro

rotigotine · Patch, Extended Release

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
Neupro
Generic name
rotigotine
Dosage form
Patch, Extended Release
Route
Transdermal
Marketing category
NDA · NDA
Labeler
UCB, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
6
NDC product codes
6
Packages
12
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Rotigotine 1 mg/24h — —
Rotigotine 2 mg/24h — —
Rotigotine 3 mg/24h — —
Rotigotine 4 mg/24h — —
Rotigotine 6 mg/24h — —
Rotigotine 8 mg/24h — —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Patch, Extended Release
Route of administration
Transdermal
Presentations
18

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
Dopamine Agonists [MoA] MoA 9 members — no class page
Nonergot Dopamine Agonist [EPC] EPC 9 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
021829
Application type
NDA · New Drug Application
Approval date
May 9, 2007
Sponsor
UCB INC
Products on application
6
Submissions recorded
13
Products approved under application 021829.
Product Trade name Form Strength Ingredient Status TE Flags
021829-001 NEUPRO FILM, EXTENDED RELEASE ROTIGOTINE Prescription — RLD RS
021829-002 NEUPRO FILM, EXTENDED RELEASE ROTIGOTINE Prescription — RLD
021829-003 NEUPRO FILM, EXTENDED RELEASE ROTIGOTINE Prescription — RLD
021829-004 NEUPRO FILM, EXTENDED RELEASE ROTIGOTINE Prescription — RLD
021829-005 NEUPRO FILM, EXTENDED RELEASE ROTIGOTINE Prescription — RLD
021829-006 NEUPRO FILM, EXTENDED RELEASE ROTIGOTINE Prescription — RLD

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
8246979 September 1, 2027 001 No U-1272 September 11, 2012
8246979 September 1, 2027 001 No U-1273 September 11, 2012
8246979 September 1, 2027 002 No U-1272 —
8246979 September 1, 2027 002 No U-1273 —
8246979 September 1, 2027 003 No U-1272 —
8246979 September 1, 2027 003 No U-1273 —
8246979 September 1, 2027 004 No U-1272 —
8246979 September 1, 2027 004 No U-1273 —
8246979 September 1, 2027 005 No U-1273 —
8246979 September 1, 2027 005 No U-1272 —
8246979 September 1, 2027 006 No U-1273 —
8246979 September 1, 2027 006 No U-1272 —
10350174 December 22, 2030 001 No July 18, 2019
10130589 December 22, 2030 001 No November 30, 2018
10130589 December 22, 2030 002 No November 30, 2018
10350174 December 22, 2030 002 No July 18, 2019
10350174 December 22, 2030 003 No July 18, 2019
10130589 December 22, 2030 003 No November 30, 2018
10130589 December 22, 2030 004 No November 30, 2018
10350174 December 22, 2030 004 No July 18, 2019
10130589 December 22, 2030 005 No November 30, 2018
10350174 December 22, 2030 005 No July 18, 2019
10130589 December 22, 2030 006 No November 30, 2018
10350174 December 22, 2030 006 No July 18, 2019
9925150 March 1, 2032 001 No April 2, 2018
9925150 March 1, 2032 002 No April 2, 2018
9925150 March 1, 2032 003 No April 2, 2018
9925150 March 1, 2032 004 No April 2, 2018
9925150 March 1, 2032 005 No April 2, 2018
9925150 March 1, 2032 006 No April 2, 2018

Approval history

Source: Drugs@FDA
Most recent submissions on application 021829.
Type No. Action Status Date Review
Supplement 22 Labeling Approved July 12, 2021 Standard
Supplement 21 Labeling Approved July 12, 2021 Standard
Supplement 17 Labeling Approved April 24, 2020 Standard
Supplement 19 Labeling Approved April 3, 2020 901 Required
Supplement 16 Labeling Approved January 18, 2019 Standard
Supplement 15 Labeling Approved November 29, 2018 Standard
Supplement 11 Manufacturing (CMC) Approved January 30, 2017 Standard
Supplement 10 Manufacturing (CMC) Approved June 3, 2016 Standard
Supplement 9 Manufacturing (CMC) Approved September 10, 2015 Standard
Supplement 7 Labeling Approved February 26, 2015 Standard
Supplement 2 Efficacy Approved April 2, 2012 Standard
Supplement 1 Efficacy Approved April 2, 2012 Standard
Original application 1 Type 1 - New Molecular Entity Approved May 9, 2007 Standard

Review documents

  • 0 · Supplement · July 14, 2021
  • 0 · Supplement · July 14, 2021
  • 0 · Supplement · July 14, 2021
  • 0 · Supplement · July 14, 2021
  • 0 · Supplement · May 5, 2020
  • 0 · Supplement · April 28, 2020
  • 0 · Supplement · April 27, 2020
  • 0 · Supplement · April 6, 2020
  • 0 · Supplement · January 22, 2019
  • 0 · Supplement · January 22, 2019
  • 0 · Supplement · December 20, 2018
  • 0 · Supplement · November 30, 2018
  • 0 · Supplement · March 2, 2015
  • 0 · Supplement · February 27, 2015
  • 0 · Supplement · April 4, 2012
  • 0 · Supplement · April 4, 2012
  • 0 · Supplement · April 2, 2012
  • 0 · Supplement · April 2, 2012
  • 0 · Supplement · April 2, 2012
  • 0 · Supplement · April 2, 2012
  • 0 · Original application · July 2, 2007
  • 0 · Original application · May 16, 2007
  • 0 · Original application · May 10, 2007
  • 0 · Original application · May 10, 2007

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
50474-801-03 50474-801 UCB, Inc. 30 POUCH in 1 CARTON (50474-801-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH April 2, 2012
50474-801-17 50474-801 UCB, Inc. 7 POUCH in 1 CARTON (50474-801-17) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH April 2, 2012
50474-802-03 50474-802 UCB, Inc. 30 POUCH in 1 CARTON (50474-802-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH April 2, 2012
50474-802-17 50474-802 UCB, Inc. 7 POUCH in 1 CARTON (50474-802-17) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH April 2, 2012
50474-803-03 50474-803 UCB, Inc. 30 POUCH in 1 CARTON (50474-803-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH April 2, 2012
50474-803-17 50474-803 UCB, Inc. 7 POUCH in 1 CARTON (50474-803-17) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH April 2, 2012
50474-804-03 50474-804 UCB, Inc. 30 POUCH in 1 CARTON (50474-804-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH April 2, 2012
50474-804-17 50474-804 UCB, Inc. 7 POUCH in 1 CARTON (50474-804-17) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH April 2, 2012
50474-805-03 50474-805 UCB, Inc. 30 POUCH in 1 CARTON (50474-805-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH April 2, 2012
50474-805-17 50474-805 UCB, Inc. 7 POUCH in 1 CARTON (50474-805-17) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH April 2, 2012
50474-806-03 50474-806 UCB, Inc. 30 POUCH in 1 CARTON (50474-806-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH April 2, 2012
50474-806-17 50474-806 UCB, Inc. 7 POUCH in 1 CARTON (50474-806-17) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH April 2, 2012
50474-801 50474-801 UCB, Inc. — April 2, 2012
50474-802 50474-802 UCB, Inc. — April 2, 2012
50474-803 50474-803 UCB, Inc. — April 2, 2012
50474-804 50474-804 UCB, Inc. — April 2, 2012
50474-805 50474-805 UCB, Inc. — April 2, 2012
50474-806 50474-806 UCB, Inc. — April 2, 2012

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.