FDA.reportPublic FDA data

Ropinirole Hydrochloride

Product NDC
55648-174
11-digit product format
556480174
Labeler code
55648
Product ID
55648-174_04e661d1-6156-43d0-abbd-64be8eca1666
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Wockhardt Limited
Application
ANDA079050
Marketing category
ANDA
Marketing start
2008-05-29
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
3 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
55648-174-012020-01-31C16284748780-19d75b9d1-0b31-f424-e053-dadaa90a57ceRopinirole Tablets, USP
55648-174-022020-01-31C16284748780-19d75b9d1-0b31-f424-e053-dadaa90a57ceRopinirole Tablets, USP
55648-174-032020-01-31C16284748780-19d75b9d1-0b31-f424-e053-dadaa90a57ceRopinirole Tablets, USP
55648-174-042020-01-31C16284748780-19d75b9d1-0b31-f424-e053-dadaa90a57ceRopinirole Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-174-01Ropinirole Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
55648-174-02Ropinirole Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1002
55648-174-03Ropinirole Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5002
55648-174-04Ropinirole Hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED102
55648-174-04Ropinirole Hydrochloride10 in 1 CARTONTABLET, FILM COATED102

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
CARMINIC ACIDINACTIVE INGREDIENTCID8Z8N95NROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-174ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [WOCKHARDT LIMITED]2Legacy NDC, 5 package rows20130307_414cd6c4-4926-4dfc-93c4-f04f4b7eeac3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
312846rOPINIRole HCl 0.5 MG Oral TabletPSN414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
314208rOPINIRole HCl 1 MG Oral TabletPSN414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
312847rOPINIRole HCl 2 MG Oral TabletPSN414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
283858rOPINIRole HCl 3 MG Oral TabletPSN414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
562704rOPINIRole HCl 4 MG Oral TabletPSN414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
312849rOPINIRole HCl 5 MG Oral TabletPSN414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
312845ropinirole 0.25 MG Oral TabletSCD414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
312846ropinirole 0.5 MG Oral TabletSCD414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
314208ropinirole 1 MG Oral TabletSCD414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
312847ropinirole 2 MG Oral TabletSCD414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
283858ropinirole 3 MG Oral TabletSCD414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
562704ropinirole 4 MG Oral TabletSCD414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
312849ropinirole 5 MG Oral TabletSCD414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
283858ropinirole 3 MG (as ropinirole hydrochloride) Oral TabletSY414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY414cd6c4-4926-4dfc-93c4-f04f4b7eeac32
312849ropinirole 5 MG (as ropinirole hydrochloride) Oral TabletSY414cd6c4-4926-4dfc-93c4-f04f4b7eeac32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-174-015564801740130 in 1 BOTTLEHistorical
55648-174-0255648017402100 in 1 BOTTLEHistorical
55648-174-0355648017403500 in 1 BOTTLEHistorical
55648-174-045564801740410 in 1 BLISTER PACKHistorical