FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
43547-601
11-digit product format
435470601
Labeler code
43547
Product ID
43547-601_bb48dd84-da25-4221-bdc7-2039e4300ed3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
SOLCO HEALTHCARE US, LLC
Application
ANDA078110
Marketing category
ANDA
Marketing start
2011-09-20
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 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
43547-601-10ropinirole hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
43547-601-50ropinirole hydrochloride500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-601-10EA - Each43547-601d677b47e-b5be-41d5-bf88-893d07f6dac112022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-601ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]2Current NDC, Legacy NDC, 2 package rows20220309_5823b3a2-3256-4d94-97b4-ec6b940312f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN5823b3a2-3256-4d94-97b4-ec6b940312f44
312846rOPINIRole HCl 0.5 MG Oral TabletPSN5823b3a2-3256-4d94-97b4-ec6b940312f44
314208rOPINIRole HCl 1 MG Oral TabletPSN5823b3a2-3256-4d94-97b4-ec6b940312f44
312847rOPINIRole HCl 2 MG Oral TabletPSN5823b3a2-3256-4d94-97b4-ec6b940312f44
283858rOPINIRole HCl 3 MG Oral TabletPSN5823b3a2-3256-4d94-97b4-ec6b940312f44
562704rOPINIRole HCl 4 MG Oral TabletPSN5823b3a2-3256-4d94-97b4-ec6b940312f44
312849rOPINIRole HCl 5 MG Oral TabletPSN5823b3a2-3256-4d94-97b4-ec6b940312f44
312845ropinirole 0.25 MG Oral TabletSCD5823b3a2-3256-4d94-97b4-ec6b940312f44
312846ropinirole 0.5 MG Oral TabletSCD5823b3a2-3256-4d94-97b4-ec6b940312f44
314208ropinirole 1 MG Oral TabletSCD5823b3a2-3256-4d94-97b4-ec6b940312f44
312847ropinirole 2 MG Oral TabletSCD5823b3a2-3256-4d94-97b4-ec6b940312f44
283858ropinirole 3 MG Oral TabletSCD5823b3a2-3256-4d94-97b4-ec6b940312f44
562704ropinirole 4 MG Oral TabletSCD5823b3a2-3256-4d94-97b4-ec6b940312f44
312849ropinirole 5 MG Oral TabletSCD5823b3a2-3256-4d94-97b4-ec6b940312f44
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY5823b3a2-3256-4d94-97b4-ec6b940312f44
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY5823b3a2-3256-4d94-97b4-ec6b940312f44
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY5823b3a2-3256-4d94-97b4-ec6b940312f44
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY5823b3a2-3256-4d94-97b4-ec6b940312f44
283858ropinirole 3 MG (as ropinirole hydrochloride) Oral TabletSY5823b3a2-3256-4d94-97b4-ec6b940312f44
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY5823b3a2-3256-4d94-97b4-ec6b940312f44
312849ropinirole 5 MG (as ropinirole hydrochloride) Oral TabletSY5823b3a2-3256-4d94-97b4-ec6b940312f44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-601-1043547060110100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-601-10) 2011-09-200000-00-00NoNoCurrent
43547-601-5043547060150500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-601-50) 2011-09-200000-00-00NoNoCurrent