FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
51655-360
11-digit product format
516550360
Labeler code
51655
Product ID
51655-360_4b3480bd-bd53-1325-e063-6394a90ad76c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078110
Marketing category
ANDA
Marketing start
2020-05-28
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
.25 mg/1
Pharmacologic classes
Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ropinirole hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROPINIROLE HYDROCHLORIDE.25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui312845

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc920868-8845-b908-7ca8-0dee3e345af5Product name220230123
e24bc1b4-1e16-908e-3d09-29da3ca2fb1fProduct name220170517

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-360-262023-11-13C16284748780-1f386c64a-49b8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997
51655-360-262023-01-30C16284748780-1f386c64a-49b8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ROPINIROLE TABLETS safely and effectively. See full prescribing information for ROPINIROLE TABLETS. ROPINIROLE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-360-26ropinirole hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-360ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 1 package rows20231114_ab6d21b6-2584-4b97-e053-2a95a90adc50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSNab6d21b6-2584-4b97-e053-2a95a90adc504
312845ropinirole 0.25 MG Oral TabletSCDab6d21b6-2584-4b97-e053-2a95a90adc504
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSYab6d21b6-2584-4b97-e053-2a95a90adc504

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-360-265165503602690 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-360-26) 2020-05-280000-00-00NoNoCurrent