FDA.reportPublic FDA data

Ropinirole

Product NDC
10135-678
11-digit product format
101350678
Labeler code
10135
Product ID
10135-678_441e0572-3413-1a21-e063-6294a90a8e6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA079165
Marketing category
ANDA
Marketing start
2019-03-15
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
4 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 HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui283858, 312845, 312846, 312847, 312849, 314208, 562704

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc920868-8845-b908-7ca8-0dee3e345af5Product name220230123
e24bc1b4-1e16-908e-3d09-29da3ca2fb1fProduct name220170517

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-678-012021-02-12C16284748780-1ba0f9c33-3a20-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
10135-678-012021-01-29C16284748780-1ba0f9c33-3a20-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-678-01Ropinirole100 in 1 BOTTLETABLET, FILM COATED10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-678-01EA - Each10135-6783072a176-e166-4853-84e8-45b084e9f61712019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-678ROPINIROLE TABLET, FILM COATED [MARLEX PHARMACEUTICALS INC]9Current NDC, Legacy NDC, 1 package rows20241019_35d90f6f-3116-4afa-be2d-b65c160e8ab3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN35d90f6f-3116-4afa-be2d-b65c160e8ab310
312846rOPINIRole HCl 0.5 MG Oral TabletPSN35d90f6f-3116-4afa-be2d-b65c160e8ab310
314208rOPINIRole HCl 1 MG Oral TabletPSN35d90f6f-3116-4afa-be2d-b65c160e8ab310
312847rOPINIRole HCl 2 MG Oral TabletPSN35d90f6f-3116-4afa-be2d-b65c160e8ab310
283858rOPINIRole HCl 3 MG Oral TabletPSN35d90f6f-3116-4afa-be2d-b65c160e8ab310
562704rOPINIRole HCl 4 MG Oral TabletPSN35d90f6f-3116-4afa-be2d-b65c160e8ab310
312849rOPINIRole HCl 5 MG Oral TabletPSN35d90f6f-3116-4afa-be2d-b65c160e8ab310
312845ropinirole 0.25 MG Oral TabletSCD35d90f6f-3116-4afa-be2d-b65c160e8ab310
312846ropinirole 0.5 MG Oral TabletSCD35d90f6f-3116-4afa-be2d-b65c160e8ab310
314208ropinirole 1 MG Oral TabletSCD35d90f6f-3116-4afa-be2d-b65c160e8ab310
312847ropinirole 2 MG Oral TabletSCD35d90f6f-3116-4afa-be2d-b65c160e8ab310
283858ropinirole 3 MG Oral TabletSCD35d90f6f-3116-4afa-be2d-b65c160e8ab310
562704ropinirole 4 MG Oral TabletSCD35d90f6f-3116-4afa-be2d-b65c160e8ab310
312849ropinirole 5 MG Oral TabletSCD35d90f6f-3116-4afa-be2d-b65c160e8ab310
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY35d90f6f-3116-4afa-be2d-b65c160e8ab310
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY35d90f6f-3116-4afa-be2d-b65c160e8ab310
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY35d90f6f-3116-4afa-be2d-b65c160e8ab310
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY35d90f6f-3116-4afa-be2d-b65c160e8ab310
283858ropinirole 3 MG (as ropinirole hydrochloride) Oral TabletSY35d90f6f-3116-4afa-be2d-b65c160e8ab310
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY35d90f6f-3116-4afa-be2d-b65c160e8ab310
312849ropinirole 5 MG (as ropinirole hydrochloride) Oral TabletSY35d90f6f-3116-4afa-be2d-b65c160e8ab310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10135-678-0110135067801100 TABLET, FILM COATED in 1 BOTTLE (10135-678-01) 2019-03-150000-00-00NoNoCurrent