ropinirole hydrochloride

Product NDC
50090-1330
11-digit product format
500901330
Labeler code
50090
Product ID
50090-1330_7cb28ad9-c0e7-42a6-9ce0-82ab6d0b6aa5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078110
Marketing category
ANDA
Marketing start
2011-09-20
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 hydrochloride
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
50090-1330-0ropinirole hydrochloride100 in 1 BOTTLETABLET, FILM COATED10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1330-0EA - Each50090-1330d5bca7f5-eef5-44d6-a523-f3bf855b6fe612018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1330ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 1 package rows20230302_9c4dacc6-cebc-4f42-85fc-41083512b290.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN9c4dacc6-cebc-4f42-85fc-41083512b29018
312845ropinirole 0.25 MG Oral TabletSCD9c4dacc6-cebc-4f42-85fc-41083512b29018
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY9c4dacc6-cebc-4f42-85fc-41083512b29018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1330-050090133000100 TABLET, FILM COATED in 1 BOTTLE (50090-1330-0) 2014-11-280000-00-00NoNoCurrent