FDA.reportPublic FDA data

ropinirole

Product NDC
71335-1167
11-digit product format
713351167
Labeler code
71335
Product ID
71335-1167_8b719be2-eaa2-4300-9e6d-806b6fe8a622
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204022
Marketing category
ANDA
Marketing start
2018-10-17
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
2 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 HYDROCHLORIDE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiD7ZD41RZI9
Rxcui312847

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
71335-1167-1ropinirole30 in 1 BOTTLETABLET, FILM COATED3013
71335-1167-2ropinirole60 in 1 BOTTLETABLET, FILM COATED6013
71335-1167-3ropinirole90 in 1 BOTTLETABLET, FILM COATED9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1167-1EA - Each71335-1167fcb428ff-b113-4d97-8eee-6b4ad314cd7812023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1167ROPINIROLE TABLET, FILM COATED [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 3 package rows20241116_ceb3a0cb-8677-4acd-8313-5498201e81d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312847rOPINIRole HCl 2 MG Oral TabletPSNceb3a0cb-8677-4acd-8313-5498201e81d913
312847ropinirole 2 MG Oral TabletSCDceb3a0cb-8677-4acd-8313-5498201e81d913
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSYceb3a0cb-8677-4acd-8313-5498201e81d913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1167-17133511670130 TABLET, FILM COATED in 1 BOTTLE (71335-1167-1) 2019-03-220000-00-00NoNoCurrent
71335-1167-27133511670260 TABLET, FILM COATED in 1 BOTTLE (71335-1167-2) 2024-10-310000-00-00NoNoCurrent
71335-1167-37133511670390 TABLET, FILM COATED in 1 BOTTLE (71335-1167-3) 2024-10-310000-00-00NoNoCurrent