NDC codes

FDA NDC Directory
Product NDC (as listed)43547-556Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0556Add 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
43547-556-034354705560330 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-556-03)Marketed from Mar 22, 2022
43547-556-094354705560990 TABLET, EXTENDED RELEASE in 1 BOTTLE (43547-556-09)Marketed from Mar 22, 2022

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 — 6 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204413
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 43547-556_9bbec058-00a5-4353-bd58-426ddb0b2020SPL ID 9bbec058-00a5-4353-bd58-426ddb0b2020SPL set ID 213dd2f4-4a71-456c-b3c7-b709c7bd7445RxCUI 799054, 799055, 799056, 824959, 848582UNII 030PYR8953UPC 0343547554033, 0343547557034, 0343547556037, 0343547555030, 0343547558031
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

N443547055603 followed by a unit qualifier and the quantity

Package 43547-0556-03. 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 indicated for the treatment of Parkinson’s disease. Ropinirole extended-release tablets are a non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204413

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

FDA NDC Directory listings under ANDA 204413
ProductStrengthForm · routeLabelerProduct NDC
RopiniroleRopinirole 8 mg/1Tablet, Extended releaseOralSolco Healthcare US, LLC43547-557
RopiniroleRopinirole 2 mg/1Tablet, Extended releaseOralSolco Healthcare US, LLC43547-554
RopiniroleRopinirole 4 mg/1Tablet, Extended releaseOralSolco Healthcare US, LLC43547-555
RopiniroleRopinirole 12 mg/1Tablet, Extended releaseOralSolco Healthcare US, LLC43547-558

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