FDA.reportPublic FDA data

ROPINIROLE

Product NDC
46708-030
11-digit product format
467080030
Labeler code
46708
Product ID
46708-030_aad4b153-ed5a-4781-ba0f-fb4bcf990057
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPINIROLE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA090429
Marketing category
ANDA
Marketing start
2013-09-12
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-030-31ROPINIROLE100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-030ROPINIROLE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 1 package rows20241225_9a25f575-09ab-4d32-b73e-5426f08c00c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN9a25f575-09ab-4d32-b73e-5426f08c00c45
312846rOPINIRole HCl 0.5 MG Oral TabletPSN9a25f575-09ab-4d32-b73e-5426f08c00c45
314208rOPINIRole HCl 1 MG Oral TabletPSN9a25f575-09ab-4d32-b73e-5426f08c00c45
312847rOPINIRole HCl 2 MG Oral TabletPSN9a25f575-09ab-4d32-b73e-5426f08c00c45
283858rOPINIRole HCl 3 MG Oral TabletPSN9a25f575-09ab-4d32-b73e-5426f08c00c45
562704rOPINIRole HCl 4 MG Oral TabletPSN9a25f575-09ab-4d32-b73e-5426f08c00c45
312849rOPINIRole HCl 5 MG Oral TabletPSN9a25f575-09ab-4d32-b73e-5426f08c00c45
312845ropinirole 0.25 MG Oral TabletSCD9a25f575-09ab-4d32-b73e-5426f08c00c45
312846ropinirole 0.5 MG Oral TabletSCD9a25f575-09ab-4d32-b73e-5426f08c00c45
314208ropinirole 1 MG Oral TabletSCD9a25f575-09ab-4d32-b73e-5426f08c00c45
312847ropinirole 2 MG Oral TabletSCD9a25f575-09ab-4d32-b73e-5426f08c00c45
283858ropinirole 3 MG Oral TabletSCD9a25f575-09ab-4d32-b73e-5426f08c00c45
562704ropinirole 4 MG Oral TabletSCD9a25f575-09ab-4d32-b73e-5426f08c00c45
312849ropinirole 5 MG Oral TabletSCD9a25f575-09ab-4d32-b73e-5426f08c00c45
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY9a25f575-09ab-4d32-b73e-5426f08c00c45
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY9a25f575-09ab-4d32-b73e-5426f08c00c45
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY9a25f575-09ab-4d32-b73e-5426f08c00c45
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY9a25f575-09ab-4d32-b73e-5426f08c00c45
283858ropinirole 3 MG (as ropinirole hydrochloride) Oral TabletSY9a25f575-09ab-4d32-b73e-5426f08c00c45
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY9a25f575-09ab-4d32-b73e-5426f08c00c45
312849ropinirole 5 MG (as ropinirole hydrochloride) Oral TabletSY9a25f575-09ab-4d32-b73e-5426f08c00c45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-030-304670800303030 TABLET, FILM COATED in 1 BOTTLE (46708-030-30) 2013-09-120000-00-00NoNoCurrent
46708-030-3146708003031100 TABLET, FILM COATED in 1 BOTTLE (46708-030-31) 2013-09-120000-00-00NoNoCurrent