FDA.reportPublic FDA data

ROPINIROLE HYDROCHLORIDE

Product NDC
50090-3304
11-digit product format
500903304
Labeler code
50090
Product ID
50090-3304_c5a52b76-b1a0-4416-82cf-d495fa49e754
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROPINIROLE HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090429
Marketing category
ANDA
Marketing start
2016-01-29
Marketing end
0000-00-00
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
1 mg/1
Pharmacologic classes
Dopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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
50090-3304-02023-01-30C16284748780-1f386c64a-0f6c-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
50090-3304-12023-01-30C16284748780-1f386c64a-0f6c-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
50090-3304-0ROPINIROLE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED305
50090-3304-1ROPINIROLE HYDROCHLORIDE90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3304-0EA - Each50090-3304b6dd226e-aa82-42b5-996c-df87bb5ae17412019-05-02
50090-3304-1EA - Each50090-3304fb7ceef3-b933-4bbd-8c9a-1bb4b7c7c48812020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3304ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210417_4a49d997-6da9-4085-b488-b399a8b828a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314208rOPINIRole HCl 1 MG Oral TabletPSN4a49d997-6da9-4085-b488-b399a8b828a65
314208ropinirole 1 MG Oral TabletSCD4a49d997-6da9-4085-b488-b399a8b828a65
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSY4a49d997-6da9-4085-b488-b399a8b828a65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3304-05009033040030 TABLET, FILM COATED in 1 BOTTLE (50090-3304-0) 2017-12-180000-00-00NoNoCurrent
50090-3304-15009033040190 TABLET, FILM COATED in 1 BOTTLE (50090-3304-1) 2017-12-150000-00-00NoNoCurrent