FDA.reportPublic FDA data

ropinirole hydrochloride

Product NDC
50268-743
11-digit product format
502680743
Labeler code
50268
Product ID
50268-743_2b4c1c97-dc70-3801-e063-6394a90a7faf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ropinirole hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA078110
Marketing category
ANDA
Marketing start
2022-08-19
Substance
ROPINIROLE HYDROCHLORIDE
Active strength
1 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 HYDROCHLORIDE1 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
50268-743-11ropinirole hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED12
50268-743-15ropinirole hydrochloride50 in 1 BOXTABLET, FILM COATED502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-743ROPINIROLE HYDROCHLORIDE TABLET, FILM COATED [AVPAK]2Current NDC, Legacy NDC, 2 package rows20250112_e699a31a-25fc-554b-e053-2a95a90a843a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312845rOPINIRole HCl 0.25 MG Oral TabletPSNe699a31a-25fc-554b-e053-2a95a90a843a2
312846rOPINIRole HCl 0.5 MG Oral TabletPSNe699a31a-25fc-554b-e053-2a95a90a843a2
314208rOPINIRole HCl 1 MG Oral TabletPSNe699a31a-25fc-554b-e053-2a95a90a843a2
312847rOPINIRole HCl 2 MG Oral TabletPSNe699a31a-25fc-554b-e053-2a95a90a843a2
312845ropinirole 0.25 MG Oral TabletSCDe699a31a-25fc-554b-e053-2a95a90a843a2
312846ropinirole 0.5 MG Oral TabletSCDe699a31a-25fc-554b-e053-2a95a90a843a2
314208ropinirole 1 MG Oral TabletSCDe699a31a-25fc-554b-e053-2a95a90a843a2
312847ropinirole 2 MG Oral TabletSCDe699a31a-25fc-554b-e053-2a95a90a843a2
312845ropinirole 0.25 MG (as ropinirole hydrochloride) Oral TabletSYe699a31a-25fc-554b-e053-2a95a90a843a2
312846ropinirole 0.5 MG (as ropinirole hydrochloride) Oral TabletSYe699a31a-25fc-554b-e053-2a95a90a843a2
314208ropinirole 1 MG (as ropinirole hydrochloride) Oral TabletSYe699a31a-25fc-554b-e053-2a95a90a843a2
312847ropinirole 2 MG (as ropinirole hydrochloride) Oral TabletSYe699a31a-25fc-554b-e053-2a95a90a843a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-743-11502680743111 in 1 BLISTER PACKHistorical
50268-743-155026807431550 BLISTER PACK in 1 BOX (50268-743-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-743-11) 50 blister pack2022-08-190000-00-00NoNoCurrent