FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
63629-4641
11-digit product format
636294641
Labeler code
63629
Product ID
63629-4641_db4a14bc-da4c-40aa-9596-ffb1d293e4c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078110
Marketing category
ANDA
Marketing start
2011-09-20
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
63629-4641-12024-01-30C16284748780-19d75b9cf-fe6c-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
63629-4641-1ropinirole hydrochloride90 in 1 BOTTLETABLET, FILM COATED901006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4641-1EA - Each63629-464127a3ed06-5806-4adc-a40a-0d0e12c0d3c212013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TALCINACTIVE INGREDIENT7SEV7J4R1UROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4641ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]1006Legacy NDC, 1 package rows20220505_ed314bc0-7ceb-441c-bf18-d24df66fbc5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312849rOPINIRole HCl 5 MG Oral TabletPSNed314bc0-7ceb-441c-bf18-d24df66fbc5f1006
312849ropinirole 5 MG Oral TabletSCDed314bc0-7ceb-441c-bf18-d24df66fbc5f1006
312849ropinirole 5 MG (as ropinirole hydrochloride) Oral TabletSYed314bc0-7ceb-441c-bf18-d24df66fbc5f1006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4641-16362946410190 TABLET, FILM COATED in 1 BOTTLE (63629-4641-1) 2011-12-050000-00-00NoNoCurrent