FDA.reportPublic FDA data

Ropinirole Hydrochloride

Product NDC
55648-773
11-digit product format
556480773
Labeler code
55648
Product ID
55648-773_62d19008-0fd5-4b90-a910-10bd48ac265a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA091395
Marketing category
ANDA
Marketing start
2012-08-15
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
4 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
55648-773-012020-01-31C16284748780-19d75b9d0-2e0f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ROPINIROLE extended-release tablets safely and effectively. See full prescribing information for ROPINIROLE extended-release tablets. ROPINIROLE extended-release tablets for oral use Initial U.S. Approval: 1997
55648-773-022020-01-31C16284748780-19d75b9d0-2e0f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ROPINIROLE extended-release tablets safely and effectively. See full prescribing information for ROPINIROLE extended-release tablets. ROPINIROLE extended-release tablets for oral use Initial U.S. Approval: 1997
55648-773-032020-01-31C16284748780-19d75b9d0-2e0f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ROPINIROLE extended-release tablets safely and effectively. See full prescribing information for ROPINIROLE extended-release tablets. ROPINIROLE extended-release tablets for oral use Initial U.S. Approval: 1997
55648-773-042020-01-31C16284748780-19d75b9d0-2e0f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ROPINIROLE extended-release tablets safely and effectively. See full prescribing information for ROPINIROLE extended-release tablets. ROPINIROLE extended-release tablets for oral use Initial U.S. Approval: 1997
55648-773-052020-01-31C16284748780-19d75b9d0-2e0f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ROPINIROLE extended-release tablets safely and effectively. See full prescribing information for ROPINIROLE extended-release tablets. ROPINIROLE extended-release tablets for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-773-01Ropinirole Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE301
55648-773-02Ropinirole Hydrochloride90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE901
55648-773-03Ropinirole Hydrochloride500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5001
55648-773-04Ropinirole Hydrochloride10 in 1 CARTONTABLET, FILM COATED, EXTENDED RE101
55648-773-04Ropinirole Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE101
55648-773-05Ropinirole Hydrochloride100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-773ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [WOCKHARDT LIMITED]1Legacy NDC, 6 package rows20120828_1e565a1d-8886-437b-8e61-031455732a5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
824959rOPINIRole 12 MG 24HR Extended Release Oral TabletPSN1e565a1d-8886-437b-8e61-031455732a5c1
799055rOPINIRole 2 MG 24HR Extended Release Oral TabletPSN1e565a1d-8886-437b-8e61-031455732a5c1
799056rOPINIRole 4 MG 24HR Extended Release Oral TabletPSN1e565a1d-8886-437b-8e61-031455732a5c1
848582rOPINIRole 6 MG 24HR Extended Release Oral TabletPSN1e565a1d-8886-437b-8e61-031455732a5c1
799054rOPINIRole 8 MG 24HR Extended Release Oral TabletPSN1e565a1d-8886-437b-8e61-031455732a5c1
82495924 HR ropinirole 12 MG Extended Release Oral TabletSCD1e565a1d-8886-437b-8e61-031455732a5c1
79905524 HR ropinirole 2 MG Extended Release Oral TabletSCD1e565a1d-8886-437b-8e61-031455732a5c1
79905624 HR ropinirole 4 MG Extended Release Oral TabletSCD1e565a1d-8886-437b-8e61-031455732a5c1
84858224 HR ropinirole 6 MG Extended Release Oral TabletSCD1e565a1d-8886-437b-8e61-031455732a5c1
79905424 HR ropinirole 8 MG Extended Release Oral TabletSCD1e565a1d-8886-437b-8e61-031455732a5c1
824959ropinirole 12 MG (as ropinirole hydrochloride 13.68 MG) 24 HR Extended Release Oral TabletSY1e565a1d-8886-437b-8e61-031455732a5c1
824959ropinirole 12 MG 24 HR Extended Release Oral TabletSY1e565a1d-8886-437b-8e61-031455732a5c1
799055ropinirole 2 MG (as ropinirole hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY1e565a1d-8886-437b-8e61-031455732a5c1
799055ropinirole 2 MG 24 HR Extended Release Oral TabletSY1e565a1d-8886-437b-8e61-031455732a5c1
799056ropinirole 4 MG (as ropinirole hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY1e565a1d-8886-437b-8e61-031455732a5c1
799056ropinirole 4 MG 24 HR Extended Release Oral TabletSY1e565a1d-8886-437b-8e61-031455732a5c1
848582ropinirole 6 MG (ropinirole hydrochloride 6.84 MG) 24 HR Extended Release Oral TabletSY1e565a1d-8886-437b-8e61-031455732a5c1
848582ropinirole 6 MG 24 HR Extended Release Oral TabletSY1e565a1d-8886-437b-8e61-031455732a5c1
799054ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral TabletSY1e565a1d-8886-437b-8e61-031455732a5c1
799054ropinirole 8 MG 24 HR Extended Release Oral TabletSY1e565a1d-8886-437b-8e61-031455732a5c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-773-015564807730130 in 1 BOTTLEHistorical
55648-773-025564807730290 in 1 BOTTLEHistorical
55648-773-0355648077303500 in 1 BOTTLEHistorical
55648-773-045564807730410 in 1 CARTONHistorical
55648-773-0555648077305100 in 1 BOTTLEHistorical