FDA.reportPublic FDA data

Ropinirole

Product NDC
55111-662
11-digit product format
551110662
Labeler code
55111
Product ID
55111-662_78d63517-2d1a-fc70-4ffb-3ebbfa065218
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Dr. Reddys Laboratories Limited
Application
ANDA201576
Marketing category
ANDA
Marketing start
2012-06-06
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
8 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 HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui799054, 799055, 799056, 824959, 848582

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
55111-662-05Ropinirole500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50010
55111-662-30Ropinirole30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3010
55111-662-90Ropinirole90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-662-30EA - Each55111-662636a3cfe-38ea-4af5-a57f-ac8e7cf35c9f12012-07-24
55111-662-90EA - Each55111-66266de0542-a1f9-41a9-96bd-6c760847b10b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ropinirole HydrochlorideACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
RopiniroleACTIVE MOIETY030PYR8953ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
magnesium stearateINACTIVE INGREDIENT70097M6I30ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
povidoneINACTIVE INGREDIENTFZ989GH94EROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6
triethyl citrateINACTIVE INGREDIENT8Z96QXD6UMROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-662ROPINIROLE TABLET, FILM COATED, EXTENDED RELEASE [DR. REDDYS LABORATORIES LIMITED]10Current NDC, Legacy NDC, 3 package rows20240103_ec0612a1-ccb1-bb51-8881-04faf491e093.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
824959rOPINIRole 12 MG 24HR Extended Release Oral TabletPSNec0612a1-ccb1-bb51-8881-04faf491e09310
799055rOPINIRole 2 MG 24HR Extended Release Oral TabletPSNec0612a1-ccb1-bb51-8881-04faf491e09310
799056rOPINIRole 4 MG 24HR Extended Release Oral TabletPSNec0612a1-ccb1-bb51-8881-04faf491e09310
848582rOPINIRole 6 MG 24HR Extended Release Oral TabletPSNec0612a1-ccb1-bb51-8881-04faf491e09310
799054rOPINIRole 8 MG 24HR Extended Release Oral TabletPSNec0612a1-ccb1-bb51-8881-04faf491e09310
82495924 HR ropinirole 12 MG Extended Release Oral TabletSCDec0612a1-ccb1-bb51-8881-04faf491e09310
79905524 HR ropinirole 2 MG Extended Release Oral TabletSCDec0612a1-ccb1-bb51-8881-04faf491e09310
79905624 HR ropinirole 4 MG Extended Release Oral TabletSCDec0612a1-ccb1-bb51-8881-04faf491e09310
84858224 HR ropinirole 6 MG Extended Release Oral TabletSCDec0612a1-ccb1-bb51-8881-04faf491e09310
79905424 HR ropinirole 8 MG Extended Release Oral TabletSCDec0612a1-ccb1-bb51-8881-04faf491e09310
824959ropinirole 12 MG (as ropinirole hydrochloride 13.68 MG) 24 HR Extended Release Oral TabletSYec0612a1-ccb1-bb51-8881-04faf491e09310
824959ropinirole 12 MG 24 HR Extended Release Oral TabletSYec0612a1-ccb1-bb51-8881-04faf491e09310
799055ropinirole 2 MG (as ropinirole hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSYec0612a1-ccb1-bb51-8881-04faf491e09310
799055ropinirole 2 MG 24 HR Extended Release Oral TabletSYec0612a1-ccb1-bb51-8881-04faf491e09310
799056ropinirole 4 MG (as ropinirole hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSYec0612a1-ccb1-bb51-8881-04faf491e09310
799056ropinirole 4 MG 24 HR Extended Release Oral TabletSYec0612a1-ccb1-bb51-8881-04faf491e09310
848582ropinirole 6 MG (ropinirole hydrochloride 6.84 MG) 24 HR Extended Release Oral TabletSYec0612a1-ccb1-bb51-8881-04faf491e09310
848582ropinirole 6 MG 24 HR Extended Release Oral TabletSYec0612a1-ccb1-bb51-8881-04faf491e09310
799054ropinirole 8 MG (as ropinirole hydrochloride 9.12 MG) 24 HR Extended Release Oral TabletSYec0612a1-ccb1-bb51-8881-04faf491e09310
799054ropinirole 8 MG 24 HR Extended Release Oral TabletSYec0612a1-ccb1-bb51-8881-04faf491e09310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55111-662-0555111066205500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-662-05) 2012-06-060000-00-00NoNoCurrent
55111-662-305511106623030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-662-30) 2012-06-060000-00-00NoNoCurrent
55111-662-905511106629090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-662-90) 2012-06-060000-00-00NoNoCurrent