FDA.reportPublic FDA data

Neupro

Product NDC
50474-801
11-digit product format
504740801
Labeler code
50474
Product ID
50474-801_385797e6-a44d-f4af-e063-6294a90a178a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rotigotine
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
UCB, Inc.
Application
NDA021829
Marketing category
NDA
Marketing start
2012-04-02
Substance
ROTIGOTINE
Active strength
1 mg/24h
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Neupro
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROTIGOTINE1 mg/24h

Harmonized Identifiers#

Field, Values table
FieldValues
Unii87T4T8BO2E
Rxcui722253, 722256, 722279, 722295, 724142, 724156, 1251912, 1251914, 1251916, 1251918, 1251920, 1251922, 1360632, 1360633

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50474-801-03Neupro30 in 1 CARTONPATCH, EXTENDED RELEASE3020
50474-801-03Neupro1 in 1 POUCHPATCH, EXTENDED RELEASE120
50474-801-17Neupro1 in 1 POUCHPATCH, EXTENDED RELEASE120
50474-801-17Neupro7 in 1 CARTONPATCH, EXTENDED RELEASE720

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50474-801NEUPRO (ROTIGOTINE) PATCH, EXTENDED RELEASE NEUPRO (ROTIGOTINE) KIT [UCB, INC.]18Current NDC, Legacy NDC, 4 package rows20240922_939e28c5-f3a9-42c0-9a2d-8d471d82a6e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1360633{7 (24 HR rotigotine 0.0833 MG/HR Transdermal System [Neupro]) / 7 (24 HR rotigotine 0.167 MG/HR Transdermal System [Neupro]) } Pack [Neupro Kit]BPCK939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1360632{7 (24 HR rotigotine 0.0833 MG/HR Transdermal System) / 7 (24 HR rotigotine 0.167 MG/HR Transdermal System) } PackGPCK939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251914Neupro 1 MG/Day 24HR Transdermal SystemPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722256Neupro 2 MG/Day 24HR Transdermal SystemPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251918Neupro 3 MG/Day 24HR Transdermal SystemPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
724142Neupro 4 MG/Day 24HR Transdermal SystemPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
724156Neupro 6 MG/Day 24HR Transdermal SystemPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251922Neupro 8 MG/Day 24HR Transdermal SystemPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1360633Neupro Titration Kit for Parkinson's disease PackPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251912rotigotine 1 MG/Day 24HR Transdermal SystemPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722253rotigotine 2 MG/Day 24HR Transdermal SystemPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1360632rotigotine 2 MG/Day 24HR Transdermal System (7) / rotigotine 4 MG/Day 24HR Transdermal System (7) PackPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251916rotigotine 3 MG/Day 24HR Transdermal SystemPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722295rotigotine 4 MG/Day 24HR Transdermal SystemPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722279rotigotine 6 MG/Day 24HR Transdermal SystemPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251920rotigotine 8 MG/Day 24HR Transdermal SystemPSN939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
125191424 HR rotigotine 0.0417 MG/HR Transdermal System [Neupro]SBD939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
72225624 HR rotigotine 0.0833 MG/HR Transdermal System [Neupro]SBD939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
125191824 HR rotigotine 0.125 MG/HR Transdermal System [Neupro]SBD939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
72414224 HR rotigotine 0.167 MG/HR Transdermal System [Neupro]SBD939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
72415624 HR rotigotine 0.25 MG/HR Transdermal System [Neupro]SBD939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
125192224 HR rotigotine 0.333 MG/HR Transdermal System [Neupro]SBD939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
125191224 HR rotigotine 0.0417 MG/HR Transdermal SystemSCD939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
72225324 HR rotigotine 0.0833 MG/HR Transdermal SystemSCD939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
125191624 HR rotigotine 0.125 MG/HR Transdermal SystemSCD939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
72229524 HR rotigotine 0.167 MG/HR Transdermal SystemSCD939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
72227924 HR rotigotine 0.25 MG/HR Transdermal SystemSCD939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
125192024 HR rotigotine 0.333 MG/HR Transdermal SystemSCD939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
125191424 HR Neupro 0.0417 MG/HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
72225624 HR Neupro 0.0833 MG/HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
125191824 HR Neupro 0.125 MG/HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
72414224 HR Neupro 0.167 MG/HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
72415624 HR Neupro 0.25 MG/HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
125192224 HR Neupro 0.333 MG/HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251914Neupro 1 MG/Day 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251914Neupro 1 MG/Day 24HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722256Neupro 2 MG/Day 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722256Neupro 2 MG/Day 24HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251918Neupro 3 MG/Day 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251918Neupro 3 MG/Day 24HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
724142Neupro 4 MG/Day 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
724142Neupro 4 MG/Day 24HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
724156Neupro 6 MG/Day 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
724156Neupro 6 MG/Day 24HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251922Neupro 8 MG/Day 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251922Neupro 8 MG/Day 24HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1360633Neupro Titration Kit for Parkinson's diseaseSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251912rotigotine 0.0417 MG/HR 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722253rotigotine 0.0833 MG/HR 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251916rotigotine 0.125 MG/HR 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722295rotigotine 0.167 MG/HR 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722279rotigotine 0.25 MG/HR 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251920rotigotine 0.333 MG/HR 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251912rotigotine 1 MG/Day 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251912rotigotine 1 MG/Day 24HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722253rotigotine 2 MG/Day 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722253rotigotine 2 MG/Day 24HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251916rotigotine 3 MG/Day 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251916rotigotine 3 MG/Day 24HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722295rotigotine 4 MG/Day 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722295rotigotine 4 MG/Day 24HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722279rotigotine 6 MG/Day 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
722279rotigotine 6 MG/Day 24HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251920rotigotine 8 MG/Day 24 HR Transdermal PatchSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020
1251920rotigotine 8 MG/Day 24HR Transdermal SystemSY939e28c5-f3a9-42c0-9a2d-8d471d82a6e020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50474-801-035047408010330 POUCH in 1 CARTON (50474-801-03) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH30 pouch2012-04-020000-00-00NoNoCurrent
50474-801-17504740801177 POUCH in 1 CARTON (50474-801-17) / 1 PATCH in 1 POUCH / 24 h in 1 PATCH7 pouch2012-04-020000-00-00NoNoCurrent