Ropinirole

Product NDC
72189-364
11-digit product format
721890364
Labeler code
72189
Product ID
72189-364_2c4c8dd5-f07a-0339-e063-6394a90afedb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA204022
Marketing category
ANDA
Marketing start
2022-06-21
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
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
72189-364-30Ropinirole30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-364-30EA - Each72189-364d3e922c4-0cf9-4604-b7e2-f4458491041d12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-364ROPINIROLE TABLET, FILM COATED [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20250123_e1fb0b51-4f8a-965d-e053-2a95a90ad936.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSNe1fb0b51-4f8a-965d-e053-2a95a90ad9362
312845ropinirole 0.25 MG Oral TabletSCDe1fb0b51-4f8a-965d-e053-2a95a90ad9362
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSYe1fb0b51-4f8a-965d-e053-2a95a90ad9362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72189-364-307218903643030 TABLET, FILM COATED in 1 BOTTLE (72189-364-30) 2022-06-210000-00-00NoNoCurrent