ropinirole

Product NDC
50090-4803
11-digit product format
500904803
Labeler code
50090
Product ID
50090-4803_964359dc-018a-469d-a2e6-cf5191a4b2ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204022
Marketing category
ANDA
Marketing start
2018-10-17
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

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
50090-4803-0ropinirole100 in 1 BOTTLETABLET, FILM COATED1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4803-0EA - Each50090-4803ad241397-e1cf-4a50-9fd3-5a9bbefefb4c12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4803ROPINIROLE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 1 package rows20240110_4f4729f8-c910-4a09-a4b4-b4243e7f0105.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN4f4729f8-c910-4a09-a4b4-b4243e7f01057
312845ropinirole 0.25 MG Oral TabletSCD4f4729f8-c910-4a09-a4b4-b4243e7f01057
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY4f4729f8-c910-4a09-a4b4-b4243e7f01057

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4803-050090480300100 TABLET, FILM COATED in 1 BOTTLE (50090-4803-0) 2019-12-200000-00-00NoNoCurrent