FDA.reportPublic FDA data

ROPINIROLE

Product NDC
55154-7888
11-digit product format
551547888
Labeler code
55154
Product ID
55154-7888_82ee8a91-c8ae-4ba4-a215-78bc057f0788
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPINIROLE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA090429
Marketing category
ANDA
Marketing start
2014-10-01
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.25 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ROPINIROLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui312845, 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
55154-7888-0ROPINIROLE1 in 1 BLISTER PACKTABLET, FILM COATED18
55154-7888-0ROPINIROLE10 in 1 BAGTABLET, FILM COATED108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7888ROPINIROLE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]7Current NDC, Legacy NDC, 2 package rows20250427_7bf874a3-4d45-41ab-9796-6729f409031c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN7bf874a3-4d45-41ab-9796-6729f409031c8
314208rOPINIRole HCl 1 MG Oral TabletPSN7bf874a3-4d45-41ab-9796-6729f409031c8
312845ropinirole 0.25 MG Oral TabletSCD7bf874a3-4d45-41ab-9796-6729f409031c8
314208ropinirole 1 MG Oral TabletSCD7bf874a3-4d45-41ab-9796-6729f409031c8
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY7bf874a3-4d45-41ab-9796-6729f409031c8
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY7bf874a3-4d45-41ab-9796-6729f409031c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7888-05515478880010 BLISTER PACK in 1 BAG (55154-7888-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2014-10-010000-00-00NoNoCurrent