FDA.reportPublic FDA data

ropinirole

Product NDC
68462-256
11-digit product format
684620256
Labeler code
68462
Product ID
68462-256_eaf797e1-337e-4fc1-bb49-29227b544fdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA090135
Marketing category
ANDA
Marketing start
2010-02-25
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
2 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ropinirole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE2 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
68462-256-01ropinirole100 in 1 BOTTLETABLET, FILM COATED10016
68462-256-10ropinirole1000 in 1 BOTTLETABLET, FILM COATED100016
68462-256-11ropinirole10 in 1 CARTONTABLET, FILM COATED1016
68462-256-11ropinirole10 in 1 BLISTER PACKTABLET, FILM COATED1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-256-01EA - Each68462-2564a0efaa9-dc7e-4a4b-9723-161a51d9c13f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
TALCINACTIVE INGREDIENT7SEV7J4R1UROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]7
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE TABLET, FILM COATED [DISPENSING SOLUTIONS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-256ROPINIROLE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]15Current NDC, Legacy NDC, 4 package rows20240104_85971b31-6f7d-421c-bf3c-5b33f3c1e781.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312847rOPINIRole HCl 2 MG Oral TabletPSNc89f68e5-d2ad-4aad-a63c-c32eff5e82c9101
312847ropinirole 2 MG Oral TabletSCDc89f68e5-d2ad-4aad-a63c-c32eff5e82c9101
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSYc89f68e5-d2ad-4aad-a63c-c32eff5e82c9101
312845rOPINIRole HCl 0.25 MG Oral TabletPSN85971b31-6f7d-421c-bf3c-5b33f3c1e78116
312846rOPINIRole HCl 0.5 MG Oral TabletPSN85971b31-6f7d-421c-bf3c-5b33f3c1e78116
314208rOPINIRole HCl 1 MG Oral TabletPSN85971b31-6f7d-421c-bf3c-5b33f3c1e78116
312847rOPINIRole HCl 2 MG Oral TabletPSN85971b31-6f7d-421c-bf3c-5b33f3c1e78116
283858rOPINIRole HCl 3 MG Oral TabletPSN85971b31-6f7d-421c-bf3c-5b33f3c1e78116
562704rOPINIRole HCl 4 MG Oral TabletPSN85971b31-6f7d-421c-bf3c-5b33f3c1e78116
312849rOPINIRole HCl 5 MG Oral TabletPSN85971b31-6f7d-421c-bf3c-5b33f3c1e78116
312845ropinirole 0.25 MG Oral TabletSCD85971b31-6f7d-421c-bf3c-5b33f3c1e78116
312846ropinirole 0.5 MG Oral TabletSCD85971b31-6f7d-421c-bf3c-5b33f3c1e78116
314208ropinirole 1 MG Oral TabletSCD85971b31-6f7d-421c-bf3c-5b33f3c1e78116
312847ropinirole 2 MG Oral TabletSCD85971b31-6f7d-421c-bf3c-5b33f3c1e78116
283858ropinirole 3 MG Oral TabletSCD85971b31-6f7d-421c-bf3c-5b33f3c1e78116
562704ropinirole 4 MG Oral TabletSCD85971b31-6f7d-421c-bf3c-5b33f3c1e78116
312849ropinirole 5 MG Oral TabletSCD85971b31-6f7d-421c-bf3c-5b33f3c1e78116
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY85971b31-6f7d-421c-bf3c-5b33f3c1e78116
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY85971b31-6f7d-421c-bf3c-5b33f3c1e78116
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY85971b31-6f7d-421c-bf3c-5b33f3c1e78116
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY85971b31-6f7d-421c-bf3c-5b33f3c1e78116
283858ropinirole 3 MG (as ropinirole hydrochloride) Oral TabletSY85971b31-6f7d-421c-bf3c-5b33f3c1e78116
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY85971b31-6f7d-421c-bf3c-5b33f3c1e78116
312849ropinirole 5 MG (as ropinirole hydrochloride) Oral TabletSY85971b31-6f7d-421c-bf3c-5b33f3c1e78116
312847rOPINIRole HCl 2 MG Oral TabletPSNcaa8f322-325d-4117-a564-c87391ebf6fe3
312847ropinirole 2 MG Oral TabletSCDcaa8f322-325d-4117-a564-c87391ebf6fe3
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSYcaa8f322-325d-4117-a564-c87391ebf6fe3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-256-0168462025601100 TABLET, FILM COATED in 1 BOTTLE (68462-256-01) 2010-02-250000-00-00NoNoCurrent
68462-256-10684620256101000 TABLET, FILM COATED in 1 BOTTLE (68462-256-10) 2010-02-250000-00-00NoNoCurrent
68462-256-116846202561110 BLISTER PACK in 1 CARTON (68462-256-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2010-02-250000-00-00NoNoCurrent