FDA.reportPublic FDA data

ROPINIROLE HYDROCHLORIDE

Product NDC
0615-8188
11-digit product format
006158188
Labeler code
0615
Product ID
0615-8188_76b08d6e-992e-4f34-b803-7ed84025a75f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPINIROLE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA090429
Marketing category
ANDA
Marketing start
2016-01-29
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.25 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 HYDROCHLORIDE.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui312845, 312846, 312847, 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
0615-8188-39ROPINIROLE HYDROCHLORIDE30 in 1 BLISTER PACKTABLET, FILM COATED3018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8188ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]18Current NDC, Legacy NDC, 1 package rows20241027_48a63d7e-c0af-4b09-863c-2af7beb2e80f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8188-390061581883930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8188-39) 2018-03-050000-00-00NoNoCurrent