ROPINIROLE
ROPINIROLE
Approved
Approval ID
c2c38b4c-b139-45f2-e053-2995a90a262c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2021
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ROPINIROLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72189-222
Application NumberANDA204022
Product Classification
M
Marketing Category
C73584
G
Generic Name
ROPINIROLE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 22, 2021
FDA Product Classification
INGREDIENTS (6)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
ROPINIROLE HYDROCHLORIDEActive
Quantity: 1 mg in 1 1
Code: D7ZD41RZI9
Classification: ACTIM
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT