FDA.reportPublic FDA data

Ropinirole

Product NDC
87063-199
11-digit product format
870630199
Labeler code
87063
Product ID
87063-199_513545f9-6299-037d-e063-6294a90a51a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ASCLEMED USA INC.
Application
ANDA079229
Marketing category
ANDA
Marketing start
2022-09-15
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.5 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 HYDROCHLORIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui312845, 312846, 312847, 314208

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
87063-199-01Ropinirole100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1001
87063-199-30Ropinirole30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
87063-199-60Ropinirole60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
87063-199-90Ropinirole90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN8f3612f0-0976-4de7-a1d6-eabaa8b75f9c1
312846rOPINIRole HCl 0.5 MG Oral TabletPSN8f3612f0-0976-4de7-a1d6-eabaa8b75f9c1
314208rOPINIRole HCl 1 MG Oral TabletPSN8f3612f0-0976-4de7-a1d6-eabaa8b75f9c1
312847rOPINIRole HCl 2 MG Oral TabletPSN8f3612f0-0976-4de7-a1d6-eabaa8b75f9c1
312845ropinirole 0.25 MG Oral TabletSCD8f3612f0-0976-4de7-a1d6-eabaa8b75f9c1
312846ropinirole 0.5 MG Oral TabletSCD8f3612f0-0976-4de7-a1d6-eabaa8b75f9c1
314208ropinirole 1 MG Oral TabletSCD8f3612f0-0976-4de7-a1d6-eabaa8b75f9c1
312847ropinirole 2 MG Oral TabletSCD8f3612f0-0976-4de7-a1d6-eabaa8b75f9c1
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY8f3612f0-0976-4de7-a1d6-eabaa8b75f9c1
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY8f3612f0-0976-4de7-a1d6-eabaa8b75f9c1
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY8f3612f0-0976-4de7-a1d6-eabaa8b75f9c1
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY8f3612f0-0976-4de7-a1d6-eabaa8b75f9c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
87063-199-0187063019901100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-199-01) 2026-05-07NoNoHistorical
87063-199-308706301993030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-199-30) 2026-05-07NoNoHistorical
87063-199-608706301996060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-199-60) 2026-05-07NoNoHistorical
87063-199-908706301999090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (87063-199-90) 2026-05-07NoNoHistorical