FDA.reportPublic FDA data

ropinirole

Product NDC
68462-255
11-digit product format
684620255
Labeler code
68462
Product ID
68462-255_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
1 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 HYDROCHLORIDE1 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
68462-255-01ropinirole100 in 1 BOTTLETABLET, FILM COATED10016
68462-255-10ropinirole1000 in 1 BOTTLETABLET, FILM COATED100016
68462-255-11ropinirole10 in 1 CARTONTABLET, FILM COATED1016
68462-255-11ropinirole10 in 1 BLISTER PACKTABLET, FILM COATED1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-255-01EA - Each68462-2551356b5cb-20c4-4d7c-8b74-2d709407b5d012012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-255ROPINIROLE 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
314208rOPINIRole HCl 1 MG Oral TabletPSNe32ef7a6-b4b6-4a22-a2ed-722255b486b4101
314208ropinirole 1 MG Oral TabletSCDe32ef7a6-b4b6-4a22-a2ed-722255b486b4101
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSYe32ef7a6-b4b6-4a22-a2ed-722255b486b4101
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
314208rOPINIRole HCl 1 MG Oral TabletPSNba358e45-09ab-46ed-986b-67affeb240a49
314208ropinirole 1 MG Oral TabletSCDba358e45-09ab-46ed-986b-67affeb240a49
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSYba358e45-09ab-46ed-986b-67affeb240a49
314208rOPINIRole HCl 1 MG Oral TabletPSN864b38b0-1d4b-4da8-9645-c1760a2080ce5
314208ropinirole 1 MG Oral TabletSCD864b38b0-1d4b-4da8-9645-c1760a2080ce5
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY864b38b0-1d4b-4da8-9645-c1760a2080ce5
314208rOPINIRole HCl 1 MG Oral TabletPSN28bc01e9-ac47-45c9-a0c1-21e85f5a23b62
314208ropinirole 1 MG Oral TabletSCD28bc01e9-ac47-45c9-a0c1-21e85f5a23b62
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY28bc01e9-ac47-45c9-a0c1-21e85f5a23b62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-255-0168462025501100 TABLET, FILM COATED in 1 BOTTLE (68462-255-01) 2010-02-250000-00-00NoNoCurrent
68462-255-10684620255101000 TABLET, FILM COATED in 1 BOTTLE (68462-255-10) 2010-02-250000-00-00NoNoCurrent
68462-255-116846202551110 BLISTER PACK in 1 CARTON (68462-255-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2010-02-250000-00-00NoNoCurrent