FDA.reportPublic FDA data

ROPINIROLE

Product NDC
62332-031
11-digit product format
623320031
Labeler code
62332
Product ID
62332-031_061e4779-5a53-4782-bb85-03abe1c98ce1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPINIROLE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA090429
Marketing category
ANDA
Marketing start
2016-01-29
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE.5 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
62332-031-31ROPINIROLE100 in 1 BOTTLETABLET, FILM COATED10021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-031ROPINIROLE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]20Current NDC, Legacy NDC, 1 package rows20241225_6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
312846rOPINIRole HCl 0.5 MG Oral TabletPSN6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
314208rOPINIRole HCl 1 MG Oral TabletPSN6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
312847rOPINIRole HCl 2 MG Oral TabletPSN6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
283858rOPINIRole HCl 3 MG Oral TabletPSN6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
562704rOPINIRole HCl 4 MG Oral TabletPSN6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
312849rOPINIRole HCl 5 MG Oral TabletPSN6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
312845ropinirole 0.25 MG Oral TabletSCD6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
312846ropinirole 0.5 MG Oral TabletSCD6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
314208ropinirole 1 MG Oral TabletSCD6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
312847ropinirole 2 MG Oral TabletSCD6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
283858ropinirole 3 MG Oral TabletSCD6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
562704ropinirole 4 MG Oral TabletSCD6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
312849ropinirole 5 MG Oral TabletSCD6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
283858ropinirole 3 MG (as ropinirole hydrochloride) Oral TabletSY6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
562704ropinirole 4 MG (as ropinirole hydrochloride) Oral TabletSY6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
312849ropinirole 5 MG (as ropinirole hydrochloride) Oral TabletSY6d1a0f9f-5fa0-43fa-83b9-0d18a129fd0c21
312845rOPINIRole HCl 0.25 MG Oral TabletPSN48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312846rOPINIRole HCl 0.5 MG Oral TabletPSN48a63d7e-c0af-4b09-863c-2af7beb2e80f18
314208rOPINIRole HCl 1 MG Oral TabletPSN48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312847rOPINIRole HCl 2 MG Oral TabletPSN48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312845ropinirole 0.25 MG Oral TabletSCD48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312846ropinirole 0.5 MG Oral TabletSCD48a63d7e-c0af-4b09-863c-2af7beb2e80f18
314208ropinirole 1 MG Oral TabletSCD48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312847ropinirole 2 MG Oral TabletSCD48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY48a63d7e-c0af-4b09-863c-2af7beb2e80f18
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSY48a63d7e-c0af-4b09-863c-2af7beb2e80f18
312846rOPINIRole HCl 0.5 MG Oral TabletPSN00c0ab77-914a-4e8a-bcb7-24cecacfebb18
312846ropinirole 0.5 MG Oral TabletSCD00c0ab77-914a-4e8a-bcb7-24cecacfebb18
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSY00c0ab77-914a-4e8a-bcb7-24cecacfebb18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-031-306233200313030 TABLET, FILM COATED in 1 BOTTLE (62332-031-30) 2016-01-290000-00-00NoNoCurrent
62332-031-3162332003131100 TABLET, FILM COATED in 1 BOTTLE (62332-031-31) 2016-01-290000-00-00NoNoCurrent