FDA.reportPublic FDA data

ropinirole

Product NDC
70518-3478
11-digit product format
705183478
Labeler code
70518
Product ID
70518-3478_4c9d34b8-c7bd-a9fa-e063-6294a90aad46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090135
Marketing category
ANDA
Marketing start
2022-08-17
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.5 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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui312846

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc920868-8845-b908-7ca8-0dee3e345af5Product name220230123
e24bc1b4-1e16-908e-3d09-29da3ca2fb1fProduct name220170517

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3478-0ropinirole30 in 1 BLISTER PACKTABLET, FILM COATED305
70518-3478-1ropinirole90 in 1 BOTTLE, PLASTICTABLET, FILM COATED905
70518-3478-2ropinirole60 in 1 BOTTLE, PLASTICTABLET, FILM COATED605
70518-3478-3ropinirole30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3478ROPINIROLE TABLET, FILM COATED [REMEDYREPACK INC.]3Current NDC, Legacy NDC, 4 package rows20240322_16752e1b-10eb-4c31-92d4-ff6c6e8466f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312846rOPINIRole HCl 0.5 MG Oral TabletPSN16752e1b-10eb-4c31-92d4-ff6c6e8466f45
312846ropinirole 0.5 MG Oral TabletSCD16752e1b-10eb-4c31-92d4-ff6c6e8466f45
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY16752e1b-10eb-4c31-92d4-ff6c6e8466f45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3478-07051834780030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3478-0) 2022-08-170000-00-00NoNoCurrent
70518-3478-17051834780190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-1) 2023-02-20NoNoHistorical
70518-3478-27051834780260 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-2) 2025-06-18NoNoHistorical
70518-3478-37051834780330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3478-3) 2026-03-09NoNoHistorical