FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
60687-588
11-digit product format
606870588
Labeler code
60687
Product ID
60687-588_2b3300f7-07e8-7648-e063-6394a90a3d62
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078110
Marketing category
ANDA
Marketing start
2021-06-09
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
1 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 hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui312845, 314208

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
60687-588-01ropinirole hydrochloride100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1005
60687-588-11ropinirole hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-588-01EA - Each60687-588d6810cfa-961c-481a-8499-26c334e0c47612021-06-02
60687-588-11EA - Each60687-588ae755b41-9a34-4f4b-b3f0-211300f4426c12021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-588ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 2 package rows20250110_6849b3c0-e36b-4bea-82f2-b33ae3d44c95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN6849b3c0-e36b-4bea-82f2-b33ae3d44c955
314208rOPINIRole HCl 1 MG Oral TabletPSN6849b3c0-e36b-4bea-82f2-b33ae3d44c955
312845ropinirole 0.25 MG Oral TabletSCD6849b3c0-e36b-4bea-82f2-b33ae3d44c955
314208ropinirole 1 MG Oral TabletSCD6849b3c0-e36b-4bea-82f2-b33ae3d44c955
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY6849b3c0-e36b-4bea-82f2-b33ae3d44c955
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY6849b3c0-e36b-4bea-82f2-b33ae3d44c955

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-588-0160687058801100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-588-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-588-11) 100 blister pack2021-06-090000-00-00NoNoCurrent
60687-588-11606870588111 in 1 BLISTER PACKHistorical