NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0447Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0447Add 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
71335-0447-17133504470130 TABLET, FILM COATED in 1 BOTTLE (71335-0447-1)Marketed from May 24, 2024
71335-0447-27133504470228 TABLET, FILM COATED in 1 BOTTLE (71335-0447-2)Marketed from May 24, 2024
71335-0447-37133504470390 TABLET, FILM COATED in 1 BOTTLE (71335-0447-3)Marketed from May 24, 2024
71335-0447-47133504470460 TABLET, FILM COATED in 1 BOTTLE (71335-0447-4)Marketed from May 24, 2024
71335-0447-571335044705100 TABLET, FILM COATED in 1 BOTTLE (71335-0447-5)Marketed from May 24, 2024

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
Generic name (nonproprietary)
ropinirole
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 090135
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 71335-0447_e68abb6b-d042-434a-b51e-86be84e3ae7aSPL ID e68abb6b-d042-434a-b51e-86be84e3ae7aSPL set ID e32ef7a6-b4b6-4a22-a2ed-722255b486b4RxCUI 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

N471335044701 followed by a unit qualifier and the quantity

Package 71335-0447-01. 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 090135

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

FDA NDC Directory listings under ANDA 090135
ProductStrengthForm · routeLabelerProduct NDC
ropiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3618
ropiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1822
RopiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralDirect_Rx72189-416
ropiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4684
ropiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-256
ropiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-253
ropiniroleRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-254
ropiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-255
ropiniroleRopinirole hydrochloride 5 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-259
ropiniroleRopinirole hydrochloride 3 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-257
ropiniroleRopinirole hydrochloride 4 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-258
ropiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0631
ropiniroleRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3478
ropiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3482
ropiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-4138

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