Prescription drug · ANDA

ropinirole hydrochloride NDC 50090-4348

Ropinirole hydrochloride 1 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-4348Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-4348Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
50090-4348-05009043480030 TABLET, FILM COATED in 1 BOTTLE (50090-4348-0)Marketed from Jun 11, 2019
50090-4348-15009043480190 TABLET, FILM COATED in 1 BOTTLE (50090-4348-1)Marketed from Jun 11, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
ropinirole hydrochloride
Generic name (nonproprietary)
ropinirole hydrochloride
Active ingredients
Ropinirole hydrochloride — 1 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078110
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 50090-4348_ca664513-9e1f-45df-8d3b-e649191dd90dSPL ID ca664513-9e1f-45df-8d3b-e649191dd90dSPL set ID a97d5e2d-4a17-4d80-9216-1b0780199502RxCUI 314208UNII D7ZD41RZI9
Pharmacologic class
Nonergot Dopamine Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N450090434800 followed by a unit qualifier and the quantity

Package 50090-4348-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Ropinirole tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (PD) and moderate-to-severe primary Restless Legs Syndrome (RLS). ( 1.1 , 1.2 ) 1.1 Parkinson’s Disease Ropinirole tablets are indicated for the treatment of Parkinson's disease. 1.2 Restless Legs Syndrome Ropinirole tablets are indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078110

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078110
ProductStrengthForm · routeLabelerProduct NDC
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralProficient Rx LP71205-825
ropinirole hydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1434
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-577
ropinirole hydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-588
ropinirole hydrochlorideRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-596
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-595
ropinirole hydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-597
ropinirole hydrochlorideRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-598
ropinirole hydrochlorideRopinirole hydrochloride 3 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-599
ropinirole hydrochlorideRopinirole hydrochloride 4 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-600
ropinirole hydrochlorideRopinirole hydrochloride 5 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-601
ropinirole hydrochlorideRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-269
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-268
ropinirole hydrochlorideRopinirole hydrochloride 4 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-273
ropinirole hydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-270
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0587
ropinirole hydrochlorideRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-271
ropinirole hydrochlorideRopinirole hydrochloride 3 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-272
ropinirole hydrochlorideRopinirole hydrochloride 5 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-274
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralAvPAK50268-741

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