Ropinirole

Product NDC
72189-494
11-digit product format
721890494
Labeler code
72189
Product ID
72189-494_2c4e39ee-1b28-61c5-e063-6394a90aeef5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA079229
Marketing category
ANDA
Marketing start
2023-06-22
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
72189-494-30Ropinirole30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-494-30EA - Each72189-494004eee16-9b6b-4491-891b-64c95c8a7b4b12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-494ROPINIROLE TABLET, FILM COATED [DIRECT_RX]2Current NDC, 1 package rows20250123_febd4b37-6039-5522-e053-6394a90a855f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314208rOPINIRole HCl 1 MG Oral TabletPSNfebd4b37-6039-5522-e053-6394a90a855f2
314208ropinirole 1 MG Oral TabletSCDfebd4b37-6039-5522-e053-6394a90a855f2
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSYfebd4b37-6039-5522-e053-6394a90a855f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-494-307218904943030 TABLET, FILM COATED in 1 BOTTLE (72189-494-30) 2023-06-22NoNoHistorical