Ropinirole

Product NDC
50090-7445
11-digit product format
500907445
Labeler code
50090
Product ID
50090-7445_d8869312-010a-4fa5-a6d4-6df0b21dc881
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079229
Marketing category
ANDA
Marketing start
2022-09-15
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
4 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 HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui562704

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
50090-7445-0Ropinirole30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7445-0EA - Each50090-74451547d1a4-41fe-4422-b395-05b35a0ecad412024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7445ROPINIROLE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20241109_339a961e-4eb0-4406-913e-ccc9e9bde084.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562704rOPINIRole HCl 4 MG Oral TabletPSN339a961e-4eb0-4406-913e-ccc9e9bde0841
562704ropinirole 4 MG Oral TabletSCD339a961e-4eb0-4406-913e-ccc9e9bde0841
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY339a961e-4eb0-4406-913e-ccc9e9bde0841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7445-05009074450030 TABLET, FILM COATED in 1 BOTTLE (50090-7445-0) 2024-11-06NoNoHistorical