NDC codes

FDA NDC Directory
Product NDC (as listed)55111-728Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55111-0728Add 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
55111-728-0555111072805500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-728-05)Marketed from Jun 6, 2012
55111-728-305511107283030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-728-30)Marketed from Jun 6, 2012
55111-728-905511107289090 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55111-728-90)Marketed from Jun 6, 2012

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 — 12 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201576
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 55111-728_78d63517-2d1a-fc70-4ffb-3ebbfa065218SPL ID 78d63517-2d1a-fc70-4ffb-3ebbfa065218SPL set ID ec0612a1-ccb1-bb51-8881-04faf491e093RxCUI 799054, 799055, 799056, 824959, 848582UNII 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

N455111072805 followed by a unit qualifier and the quantity

Package 55111-0728-05. 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 extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease. ( 1) Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201576

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

FDA NDC Directory listings under ANDA 201576
ProductStrengthForm · routeLabelerProduct NDC
RopiniroleRopinirole hydrochloride 6 mg/1Tablet, Film coated, Extended releaseOralDr. Reddys Laboratories Limited55111-727
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coated, Extended releaseOralDr. Reddys Laboratories Limited55111-659
RopiniroleRopinirole hydrochloride 4 mg/1Tablet, Film coated, Extended releaseOralDr. Reddys Laboratories Limited55111-661
RopiniroleRopinirole hydrochloride 8 mg/1Tablet, Film coated, Extended releaseOralDr. Reddys Laboratories Limited55111-662

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Ropinirole NDC 55111-728 | Med-Code