FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
43547-269
11-digit product format
435470269
Labeler code
43547
Product ID
43547-269_0e04048a-c22c-4c6b-9c00-91906541a95a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SOLCO HEALTHCARE US, LLC
Application
ANDA078110
Marketing category
ANDA
Marketing start
2011-09-20
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.5 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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE.5 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
43547-269-102020-04-08C16284748780-19d75b9d0-4cd2-f424-e053-dadaa90a57ceThese 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
43547-269-502020-04-08C16284748780-19d75b9d0-4cd2-f424-e053-dadaa90a57ceThese 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
43547-269-102020-01-31C16284748780-19d75b9d0-4cd2-f424-e053-dadaa90a57ceThese 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
43547-269-502020-01-31C16284748780-19d75b9d0-4cd2-f424-e053-dadaa90a57ceThese 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
43547-269-10ropinirole hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10017
43547-269-50ropinirole hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-269ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]15Current NDC, Legacy NDC, 2 package rows20220322_7734ef0b-584f-42dd-a8b5-adbdf4e4df93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312846rOPINIRole HCl 0.5 MG Oral TabletPSN8e23aac9-446c-43b5-89ab-fc596b766df01006
312846ropinirole 0.5 MG Oral TabletSCD8e23aac9-446c-43b5-89ab-fc596b766df01006
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY8e23aac9-446c-43b5-89ab-fc596b766df01006
312845rOPINIRole HCl 0.25 MG Oral TabletPSN7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
312846rOPINIRole HCl 0.5 MG Oral TabletPSN7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
314208rOPINIRole HCl 1 MG Oral TabletPSN7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
312847rOPINIRole HCl 2 MG Oral TabletPSN7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
283858rOPINIRole HCl 3 MG Oral TabletPSN7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
562704rOPINIRole HCl 4 MG Oral TabletPSN7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
312849rOPINIRole HCl 5 MG Oral TabletPSN7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
312845ropinirole 0.25 MG Oral TabletSCD7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
312846ropinirole 0.5 MG Oral TabletSCD7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
314208ropinirole 1 MG Oral TabletSCD7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
312847ropinirole 2 MG Oral TabletSCD7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
283858ropinirole 3 MG Oral TabletSCD7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
562704ropinirole 4 MG Oral TabletSCD7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
312849ropinirole 5 MG Oral TabletSCD7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
283858ropinirole 3 MG (as ropinirole hydrochloride) Oral TabletSY7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
312849ropinirole 5 MG (as ropinirole hydrochloride) Oral TabletSY7734ef0b-584f-42dd-a8b5-adbdf4e4df9317
312845rOPINIRole HCl 0.25 MG Oral TabletPSNe699a31a-25fc-554b-e053-2a95a90a843a2
312846rOPINIRole HCl 0.5 MG Oral TabletPSNe699a31a-25fc-554b-e053-2a95a90a843a2
314208rOPINIRole HCl 1 MG Oral TabletPSNe699a31a-25fc-554b-e053-2a95a90a843a2
312847rOPINIRole HCl 2 MG Oral TabletPSNe699a31a-25fc-554b-e053-2a95a90a843a2
312845ropinirole 0.25 MG Oral TabletSCDe699a31a-25fc-554b-e053-2a95a90a843a2
312846ropinirole 0.5 MG Oral TabletSCDe699a31a-25fc-554b-e053-2a95a90a843a2
314208ropinirole 1 MG Oral TabletSCDe699a31a-25fc-554b-e053-2a95a90a843a2
312847ropinirole 2 MG Oral TabletSCDe699a31a-25fc-554b-e053-2a95a90a843a2
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSYe699a31a-25fc-554b-e053-2a95a90a843a2
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSYe699a31a-25fc-554b-e053-2a95a90a843a2
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSYe699a31a-25fc-554b-e053-2a95a90a843a2
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSYe699a31a-25fc-554b-e053-2a95a90a843a2
312845rOPINIRole HCl 0.25 MG Oral TabletPSN70e6fca5-554e-48d4-9d11-9879009c4bd81
312846rOPINIRole HCl 0.5 MG Oral TabletPSN70e6fca5-554e-48d4-9d11-9879009c4bd81
314208rOPINIRole HCl 1 MG Oral TabletPSN70e6fca5-554e-48d4-9d11-9879009c4bd81
312847rOPINIRole HCl 2 MG Oral TabletPSN70e6fca5-554e-48d4-9d11-9879009c4bd81
312845ropinirole 0.25 MG Oral TabletSCD70e6fca5-554e-48d4-9d11-9879009c4bd81
312846ropinirole 0.5 MG Oral TabletSCD70e6fca5-554e-48d4-9d11-9879009c4bd81
314208ropinirole 1 MG Oral TabletSCD70e6fca5-554e-48d4-9d11-9879009c4bd81
312847ropinirole 2 MG Oral TabletSCD70e6fca5-554e-48d4-9d11-9879009c4bd81
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY70e6fca5-554e-48d4-9d11-9879009c4bd81
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY70e6fca5-554e-48d4-9d11-9879009c4bd81
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY70e6fca5-554e-48d4-9d11-9879009c4bd81
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY70e6fca5-554e-48d4-9d11-9879009c4bd81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-269-1043547026910100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-269-10) 2011-09-200000-00-00NoNoCurrent
43547-269-5043547026950500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-269-50) 2011-09-200000-00-00NoNoCurrent