FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
71205-825
11-digit product format
712050825
Labeler code
71205
Product ID
71205-825_89e3865c-1fe1-4f29-9606-8830df4bbe53
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078110
Marketing category
ANDA
Marketing start
2011-09-20
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

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
71205-825-30ropinirole hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
71205-825-60ropinirole hydrochloride60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
71205-825-90ropinirole hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-825-30EA - Each71205-825c2dfdad4-7c99-4954-a073-d01c4b4a76fb12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-825ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20230819_89e3865c-1fe1-4f29-9606-8830df4bbe53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSN89e3865c-1fe1-4f29-9606-8830df4bbe531
312845ropinirole 0.25 MG Oral TabletSCD89e3865c-1fe1-4f29-9606-8830df4bbe531
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSY89e3865c-1fe1-4f29-9606-8830df4bbe531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-825-307120508253030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-825-30) 2023-08-11NoNoHistorical
71205-825-607120508256060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-825-60) 2023-08-11NoNoHistorical
71205-825-907120508259090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-825-90) 2023-08-11NoNoHistorical