FDA.reportPublic FDA data

Ropinirole

Product NDC
68151-4073
11-digit product format
681514073
Labeler code
68151
Product ID
68151-4073_91ad82ed-4768-4ac3-b44e-8dc21aa03c35
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rOPINIRole
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA077852
Marketing category
ANDA
Marketing start
2008-05-05
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
E
Listing certified through
2018-12-31
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
68151-4073-22020-01-31C16284748780-19d75b9d0-78af-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use rOPINIRole Tablets USP safely and effectively. See full prescribing information for rOPINIRole Tablets USP. rOPINIRole Tablets USP, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4073-2Ropinirole1 in 1 PACKAGETABLET13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4073ROPINIROLE TABLET [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_1cdb9d61-5bbc-4026-a449-fec8c9ce5c65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314208rOPINIRole HCl 1 MG Oral TabletPSN1cdb9d61-5bbc-4026-a449-fec8c9ce5c653
314208ropinirole 1 MG Oral TabletSCD1cdb9d61-5bbc-4026-a449-fec8c9ce5c653
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY1cdb9d61-5bbc-4026-a449-fec8c9ce5c653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4073-2681514073021 in 1 PACKAGEHistorical