Neupro
These highlights do not include all the information needed to use NEUPRO safely and effectively. See full prescribing information for NEUPRO. NEUPRO (rotigotine transdermal system) Initial U.S. Approval: 2007
Approved
Approval ID
939e28c5-f3a9-42c0-9a2d-8d471d82a6e0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 27, 2022
Manufacturers
FDA
UCB, Inc.
DUNS: 028526403
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
rotigotine
PRODUCT DETAILS
NDC Product Code50474-803
Application NumberNDA021829
Marketing CategoryC73594
Route of AdministrationTRANSDERMAL
Effective DateJuly 21, 2021
Generic Namerotigotine
INGREDIENTS (5)
rotigotineActive
Quantity: 3 mg in 24 h
Code: 87T4T8BO2E
Classification: ACTIB
ascorbyl palmitateInactive
Code: QN83US2B0N
Classification: IACT
.alpha.-tocopherol, dl-Inactive
Code: 7QWA1RIO01
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
sodium metabisulfiteInactive
Code: 4VON5FNS3C
Classification: IACT
rotigotine
PRODUCT DETAILS
NDC Product Code50474-804
Application NumberNDA021829
Marketing CategoryC73594
Route of AdministrationTRANSDERMAL
Effective DateJuly 21, 2021
Generic Namerotigotine
INGREDIENTS (5)
rotigotineActive
Quantity: 4 mg in 24 h
Code: 87T4T8BO2E
Classification: ACTIB
ascorbyl palmitateInactive
Code: QN83US2B0N
Classification: IACT
sodium metabisulfiteInactive
Code: 4VON5FNS3C
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
.alpha.-tocopherol, dl-Inactive
Code: 7QWA1RIO01
Classification: IACT
rotigotine
PRODUCT DETAILS
NDC Product Code50474-802
Application NumberNDA021829
Marketing CategoryC73594
Route of AdministrationTRANSDERMAL
Effective DateJuly 21, 2021
Generic Namerotigotine
INGREDIENTS (5)
ascorbyl palmitateInactive
Code: QN83US2B0N
Classification: IACT
rotigotineActive
Quantity: 2 mg in 24 h
Code: 87T4T8BO2E
Classification: ACTIB
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
.alpha.-tocopherol, dl-Inactive
Code: 7QWA1RIO01
Classification: IACT
sodium metabisulfiteInactive
Code: 4VON5FNS3C
Classification: IACT
rotigotine
PRODUCT DETAILS
NDC Product Code50474-806
Application NumberNDA021829
Marketing CategoryC73594
Route of AdministrationTRANSDERMAL
Effective DateJuly 21, 2021
Generic Namerotigotine
INGREDIENTS (5)
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
rotigotineActive
Quantity: 8 mg in 24 h
Code: 87T4T8BO2E
Classification: ACTIB
.alpha.-tocopherol, dl-Inactive
Code: 7QWA1RIO01
Classification: IACT
ascorbyl palmitateInactive
Code: QN83US2B0N
Classification: IACT
sodium metabisulfiteInactive
Code: 4VON5FNS3C
Classification: IACT
rotigotine
PRODUCT DETAILS
NDC Product Code50474-808
Application NumberNDA021829
Marketing CategoryC73594
Route of AdministrationN/A
Effective DateJuly 21, 2021
Generic Namerotigotine
rotigotine
PRODUCT DETAILS
NDC Product Code50474-805
Application NumberNDA021829
Marketing CategoryC73594
Route of AdministrationTRANSDERMAL
Effective DateJuly 21, 2021
Generic Namerotigotine
INGREDIENTS (5)
rotigotineActive
Quantity: 6 mg in 24 h
Code: 87T4T8BO2E
Classification: ACTIB
ascorbyl palmitateInactive
Code: QN83US2B0N
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
sodium metabisulfiteInactive
Code: 4VON5FNS3C
Classification: IACT
.alpha.-tocopherol, dl-Inactive
Code: 7QWA1RIO01
Classification: IACT
rotigotine
PRODUCT DETAILS
NDC Product Code50474-801
Application NumberNDA021829
Marketing CategoryC73594
Route of AdministrationTRANSDERMAL
Effective DateJuly 21, 2021
Generic Namerotigotine
INGREDIENTS (5)
rotigotineActive
Quantity: 1 mg in 24 h
Code: 87T4T8BO2E
Classification: ACTIB
ascorbyl palmitateInactive
Code: QN83US2B0N
Classification: IACT
povidone, unspecifiedInactive
Code: FZ989GH94E
Classification: IACT
.alpha.-tocopherol, dl-Inactive
Code: 7QWA1RIO01
Classification: IACT
sodium metabisulfiteInactive
Code: 4VON5FNS3C
Classification: IACT