FDA.reportPublic FDA data

ROPINIROLE

Product NDC
72189-222
11-digit product format
721890222
Labeler code
72189
Product ID
72189-222_2c28281e-fe37-b7e4-e063-6294a90ad4f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPINIROLE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA204022
Marketing category
ANDA
Marketing start
2021-05-20
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
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
72189-222-30ROPINIROLE30 in 1 BOTTLETABLET, FILM COATED303
72189-222-60ROPINIROLE60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-222-30EA - Each72189-2221d8b8770-10a8-4fa6-b0e4-ff949053bcbc12022-01-06
72189-222-60EA - Each72189-222308448a2-b950-47a4-ae4e-80ebe12ce00312021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-222ROPINIROLE TABLET, FILM COATED [DIRECT RX]3Current NDC, Legacy NDC, 2 package rows20250121_c2c38b4c-b139-45f2-e053-2995a90a262c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314208rOPINIRole HCl 1 MG Oral TabletPSNc2c38b4c-b139-45f2-e053-2995a90a262c3
314208ropinirole 1 MG Oral TabletSCDc2c38b4c-b139-45f2-e053-2995a90a262c3
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSYc2c38b4c-b139-45f2-e053-2995a90a262c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-222-307218902223030 TABLET, FILM COATED in 1 BOTTLE (72189-222-30) 2021-05-200000-00-00NoNoCurrent
72189-222-607218902226060 TABLET, FILM COATED in 1 BOTTLE (72189-222-60) 2021-05-200000-00-00NoNoCurrent