neupro

Generic: rotigotine

Labeler: ucb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name neupro
Generic Name rotigotine
Labeler ucb, inc.
Dosage Form KIT
Manufacturer
UCB, Inc.

Identifiers & Regulatory

Product NDC 50474-808
Product ID 50474-808_385797e6-a44d-f4af-e063-6294a90a178a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021829
Listing Expiration 2026-12-31
Marketing Start 2012-04-02

Pharmacologic Class

Established (EPC)
nonergot dopamine agonist [epc]
Mechanism of Action
dopamine agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50474808
Hyphenated Format 50474-808

Supplemental Identifiers

RxCUI
722253 722256 722279 722295 724142 724156 1251912 1251914 1251916 1251918 1251920 1251922 1360632 1360633
UNII
87T4T8BO2E
NUI
N0000000117 N0000175768

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name neupro (source: ndc)
Generic Name rotigotine (source: ndc)
Application Number NDA021829 (source: ndc)
Routes
transdermal
source: label

Resolved Composition

Strengths
  • 1 mg
  • 2 mg
  • 3 mg
  • 4 mg
  • 6 mg
  • 8 mg
source: label
Packaging
  • 2 BOX in 1 KIT (50474-808-11) / 1 KIT in 1 BOX * 7 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 24 h in 1 PATCH * 7 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 24 h in 1 PATCH
source: ndc

Packages (1)

50474-808-11 2 BOX in 1 KIT (50474-808-11) / 1 KIT in 1 BOX * 7 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 24 h in 1 PATCH * 7 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 24 h in 1 PATCH

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

Neupro ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "385797e6-a44d-f4af-e063-6294a90a178a", "openfda": {"nui": ["N0000000117", "N0000175768"], "unii": ["87T4T8BO2E"], "rxcui": ["722253", "722256", "722279", "722295", "724142", "724156", "1251912", "1251914", "1251916", "1251918", "1251920", "1251922", "1360632", "1360633"], "spl_set_id": ["939e28c5-f3a9-42c0-9a2d-8d471d82a6e0"], "pharm_class_epc": ["Nonergot Dopamine Agonist [EPC]"], "pharm_class_moa": ["Dopamine Agonists [MoA]"], "manufacturer_name": ["UCB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOX in 1 KIT (50474-808-11)  / 1 KIT in 1 BOX *  7 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 24 h in 1 PATCH *  7 POUCH in 1 BOX / 1 PATCH in 1 POUCH / 24 h in 1 PATCH", "package_ndc": "50474-808-11", "marketing_start_date": "20120402"}], "brand_name": "Neupro", "product_id": "50474-808_385797e6-a44d-f4af-e063-6294a90a178a", "dosage_form": "KIT", "product_ndc": "50474-808", "generic_name": "rotigotine", "labeler_name": "UCB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Neupro", "application_number": "NDA021829", "marketing_category": "NDA", "marketing_start_date": "20120402", "listing_expiration_date": "20261231"}