FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
43547-268
11-digit product format
435470268
Labeler code
43547
Product ID
43547-268_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
.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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE.25 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
43547-268-102020-04-08C16284748780-19d75b9d0-4cd2-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
43547-268-502020-04-08C16284748780-19d75b9d0-4cd2-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
43547-268-102020-01-31C16284748780-19d75b9d0-4cd2-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
43547-268-502020-01-31C16284748780-19d75b9d0-4cd2-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
43547-268-10ropinirole hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10017
43547-268-50ropinirole hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-268-10EA - Each43547-26819f949d4-6f17-4b97-8321-c0b73dbd645912012-07-24
43547-268-50EA - Each43547-268e995dc48-7545-4f9e-bf28-3ea81de2a4db12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
COCHINEALINACTIVE INGREDIENTTZ8Z31B35MROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
TALCINACTIVE INGREDIENT7SEV7J4R1UROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE U.S., LLC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-268ROPINIROLE 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
312845rOPINIRole HCl 0.25 MG Oral TabletPSN9c4dacc6-cebc-4f42-85fc-41083512b29018
312845ropinirole 0.25 MG Oral TabletSCD9c4dacc6-cebc-4f42-85fc-41083512b29018
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY9c4dacc6-cebc-4f42-85fc-41083512b29018
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 TabletPSN6c10444a-48da-469d-bf8f-1e6e0b7e15f810
314208rOPINIRole HCl 1 MG Oral TabletPSN6c10444a-48da-469d-bf8f-1e6e0b7e15f810
312847rOPINIRole HCl 2 MG Oral TabletPSN6c10444a-48da-469d-bf8f-1e6e0b7e15f810
312845ropinirole 0.25 MG Oral TabletSCD6c10444a-48da-469d-bf8f-1e6e0b7e15f810
314208ropinirole 1 MG Oral TabletSCD6c10444a-48da-469d-bf8f-1e6e0b7e15f810
312847ropinirole 2 MG Oral TabletSCD6c10444a-48da-469d-bf8f-1e6e0b7e15f810
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY6c10444a-48da-469d-bf8f-1e6e0b7e15f810
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY6c10444a-48da-469d-bf8f-1e6e0b7e15f810
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY6c10444a-48da-469d-bf8f-1e6e0b7e15f810
312845rOPINIRole HCl 0.25 MG Oral TabletPSN6849b3c0-e36b-4bea-82f2-b33ae3d44c955
314208rOPINIRole HCl 1 MG Oral TabletPSN6849b3c0-e36b-4bea-82f2-b33ae3d44c955
312845ropinirole 0.25 MG Oral TabletSCD6849b3c0-e36b-4bea-82f2-b33ae3d44c955
314208ropinirole 1 MG Oral TabletSCD6849b3c0-e36b-4bea-82f2-b33ae3d44c955
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY6849b3c0-e36b-4bea-82f2-b33ae3d44c955
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY6849b3c0-e36b-4bea-82f2-b33ae3d44c955
312845rOPINIRole HCl 0.25 MG Oral TabletPSNab6d21b6-2584-4b97-e053-2a95a90adc504
312845ropinirole 0.25 MG Oral TabletSCDab6d21b6-2584-4b97-e053-2a95a90adc504
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSYab6d21b6-2584-4b97-e053-2a95a90adc504
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 TabletPSN89e3865c-1fe1-4f29-9606-8830df4bbe531
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 TabletSCD89e3865c-1fe1-4f29-9606-8830df4bbe531
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 TabletSY89e3865c-1fe1-4f29-9606-8830df4bbe531
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
43547-268-1043547026810100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-268-10) 2011-09-200000-00-00NoNoCurrent
43547-268-5043547026850500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-268-50) 2011-09-200000-00-00NoNoCurrent