ropinirole

Product NDC
50090-1822
11-digit product format
500901822
Labeler code
50090
Product ID
50090-1822_9928b6fc-9135-4260-b9e1-66a6d8c9a152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090135
Marketing category
ANDA
Marketing start
2010-02-25
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.25 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.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui312845, 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
50090-1822-0ropinirole100 in 1 BOTTLETABLET, FILM COATED10024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1822-0EA - Each50090-18227d379293-4e21-4395-8854-e25acf0ba88e12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1822ROPINIROLE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]22Current NDC, Legacy NDC, 1 package rows20240724_35d0074e-212b-4a1f-9cd7-974ca08d2c95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN35d0074e-212b-4a1f-9cd7-974ca08d2c9524
562704rOPINIRole HCl 4 MG Oral TabletPSN35d0074e-212b-4a1f-9cd7-974ca08d2c9524
312845ropinirole 0.25 MG Oral TabletSCD35d0074e-212b-4a1f-9cd7-974ca08d2c9524
562704ropinirole 4 MG Oral TabletSCD35d0074e-212b-4a1f-9cd7-974ca08d2c9524
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY35d0074e-212b-4a1f-9cd7-974ca08d2c9524
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY35d0074e-212b-4a1f-9cd7-974ca08d2c9524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1822-050090182200100 TABLET, FILM COATED in 1 BOTTLE (50090-1822-0) 2015-05-120000-00-00NoNoCurrent