FDA.reportPublic FDA data

Ropinirole

Product NDC
0054-0116
11-digit product format
000540116
Labeler code
0054
Product ID
0054-0116_89b0f8ed-b89f-461b-a0d7-6a52a82aa57d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rOPINIRole
Dosage form
TABLET
Route
ORAL
Labeler
West-Ward Pharmaceuticals Corp.
Application
ANDA077852
Marketing category
ANDA
Marketing start
2008-05-05
Marketing end
2020-10-09
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
0 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0054-0116-25EA - Each0054-0116f0fd923b-1e3d-4d1f-94ff-5c047ed78d6512012-07-24

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
ROPINIROLE HYDROCHLORIDEACTIVE INGREDIENTD7ZD41RZI9ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ROPINIROLEACTIVE MOIETY030PYR8953ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ROPINIROLE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN417964dc-94c1-475e-b954-9d3e6fcba0e05
312845ropinirole 0.25 MG Oral TabletSCD417964dc-94c1-475e-b954-9d3e6fcba0e05
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY417964dc-94c1-475e-b954-9d3e6fcba0e05
312845rOPINIRole HCl 0.25 MG Oral TabletPSN4c88de4d-64b8-43e1-9dbe-c38eede024a81
314208rOPINIRole HCl 1 MG Oral TabletPSN4c88de4d-64b8-43e1-9dbe-c38eede024a81
312847rOPINIRole HCl 2 MG Oral TabletPSN4c88de4d-64b8-43e1-9dbe-c38eede024a81
312845ropinirole 0.25 MG Oral TabletSCD4c88de4d-64b8-43e1-9dbe-c38eede024a81
314208ropinirole 1 MG Oral TabletSCD4c88de4d-64b8-43e1-9dbe-c38eede024a81
312847ropinirole 2 MG Oral TabletSCD4c88de4d-64b8-43e1-9dbe-c38eede024a81
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY4c88de4d-64b8-43e1-9dbe-c38eede024a81
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY4c88de4d-64b8-43e1-9dbe-c38eede024a81
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY4c88de4d-64b8-43e1-9dbe-c38eede024a81