NDC codes

FDA NDC Directory
Product NDC (as listed)68462-253Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68462-0253Add 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
68462-253-0168462025301100 TABLET, FILM COATED in 1 BOTTLE (68462-253-01)Marketed from Feb 25, 2010
68462-253-10684620253101000 TABLET, FILM COATED in 1 BOTTLE (68462-253-10)Marketed from Feb 25, 2010
68462-253-116846202531110 BLISTER PACK in 1 CARTON (68462-253-11) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Feb 25, 2010

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — .25 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 68462-253_eaf797e1-337e-4fc1-bb49-29227b544fdbSPL ID eaf797e1-337e-4fc1-bb49-29227b544fdbSPL set ID 85971b31-6f7d-421c-bf3c-5b33f3c1e781RxCUI 283858, 312845, 312846, 312847, 312849, 314208, 562704UNII D7ZD41RZI9UPC 0368462258019, 0368462253014, 0368462256015, 0368462259016, 0368462254011, 0368462255018, 0368462257012
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

N468462025301 followed by a unit qualifier and the quantity

Package 68462-0253-01. 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 1 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0447
ropiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc., USA68462-256
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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ropinirole NDC 68462-253 | Med-Code