ropinirole

Product NDC
50090-4684
11-digit product format
500904684
Labeler code
50090
Product ID
50090-4684_51031fe5-ffc7-4c4c-913f-d94cbb674c65
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
1 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 HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui314208

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
50090-4684-0ropinirole30 in 1 BOTTLETABLET, FILM COATED309
50090-4684-1ropinirole90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4684-0EA - Each50090-468495ad438e-44e2-4f31-8007-3fe1b1cf02f512023-02-06
50090-4684-1EA - Each50090-46841701f7ac-1b3b-43f5-9fcd-c12014aedac512023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4684ROPINIROLE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20231216_ba358e45-09ab-46ed-986b-67affeb240a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314208rOPINIRole HCl 1 MG Oral TabletPSNba358e45-09ab-46ed-986b-67affeb240a49
314208ropinirole 1 MG Oral TabletSCDba358e45-09ab-46ed-986b-67affeb240a49
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSYba358e45-09ab-46ed-986b-67affeb240a49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4684-05009046840030 TABLET, FILM COATED in 1 BOTTLE (50090-4684-0) 2019-11-050000-00-00NoNoCurrent
50090-4684-15009046840190 TABLET, FILM COATED in 1 BOTTLE (50090-4684-1) 2019-11-050000-00-00NoNoCurrent