FDA.reportPublic FDA data

Ropinirole

Product NDC
69452-360
11-digit product format
694520360
Labeler code
69452
Product ID
69452-360_4fb684db-c9c7-f5a9-e063-6394a90a0931
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA079229
Marketing category
ANDA
Marketing start
2022-09-15
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
3 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ropinirole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui283858, 312845, 312846, 312847, 312849, 314208, 562704

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc920868-8845-b908-7ca8-0dee3e345af5Product name220230123
e24bc1b4-1e16-908e-3d09-29da3ca2fb1fProduct name220170517

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-360-20Ropinirole100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-360ROPINIROLE TABLET, FILM COATED [BIONPHARMA INC.]3Current NDC, Legacy NDC, 1 package rows20231211_4e6b070c-50a6-4742-af3c-59b45c45735e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
312846rOPINIRole HCl 0.5 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
314208rOPINIRole HCl 1 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
312847rOPINIRole HCl 2 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
283858rOPINIRole HCl 3 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
562704rOPINIRole HCl 4 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
312849rOPINIRole HCl 5 MG Oral TabletPSN4e6b070c-50a6-4742-af3c-59b45c45735e6
312845ropinirole 0.25 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
312846ropinirole 0.5 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
314208ropinirole 1 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
312847ropinirole 2 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
283858ropinirole 3 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
562704ropinirole 4 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
312849ropinirole 5 MG Oral TabletSCD4e6b070c-50a6-4742-af3c-59b45c45735e6
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6
283858ropinirole 3 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6
312849ropinirole 5 MG (as ropinirole hydrochloride) Oral TabletSY4e6b070c-50a6-4742-af3c-59b45c45735e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-360-2069452036020100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-360-20) 2022-09-150000-00-00NoNoCurrent