FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
50090-4348
11-digit product format
500904348
Labeler code
50090
Product ID
50090-4348_ca664513-9e1f-45df-8d3b-e649191dd90d
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
1 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 hydrochloride
Listing expiration
2027-12-31

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
50090-4348-0ropinirole hydrochloride30 in 1 BOTTLETABLET, FILM COATED3014
50090-4348-1ropinirole hydrochloride90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4348-1EA - Each50090-43481b042cfe-4e39-4d4a-b1bd-fc1fd6879e5712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4348ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20231216_a97d5e2d-4a17-4d80-9216-1b0780199502.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314208rOPINIRole HCl 1 MG Oral TabletPSNa97d5e2d-4a17-4d80-9216-1b078019950214
314208ropinirole 1 MG Oral TabletSCDa97d5e2d-4a17-4d80-9216-1b078019950214
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSYa97d5e2d-4a17-4d80-9216-1b078019950214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4348-05009043480030 TABLET, FILM COATED in 1 BOTTLE (50090-4348-0) 2019-06-110000-00-00NoNoCurrent
50090-4348-15009043480190 TABLET, FILM COATED in 1 BOTTLE (50090-4348-1) 2019-06-110000-00-00NoNoCurrent