Prescription drug · ANDA

Ropinirole NDC 55154-7633

Ropinirole hydrochloride 1 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)55154-7633Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-7633Add 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
55154-7633-05515476330010 BLISTER PACK in 1 BAG (55154-7633-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 1, 2014

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 090429
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 55154-7633_28f23fb3-52a4-49b3-9aa8-8613a5e35e46SPL ID 28f23fb3-52a4-49b3-9aa8-8613a5e35e46SPL set ID 7bf874a3-4d45-41ab-9796-6729f409031cRxCUI 312845, 314208UNII D7ZD41RZI9UPC 0055154763301
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

N455154763300 followed by a unit qualifier and the quantity

Package 55154-7633-00. 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 090429

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

FDA NDC Directory listings under ANDA 090429
ProductStrengthForm · routeLabelerProduct NDC
RopiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-032
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-033
RopiniroleRopinirole hydrochloride 3 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-034
RopiniroleRopinirole hydrochloride 4 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-035
Ropinirole HydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8190
RopiniroleRopinirole hydrochloride 5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-036
Ropinirole HydrochlorideRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8191
Ropinirole HydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0829
RopiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7888
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralCoupler LLC67046-1489
RopiniroleRopinirole hydrochloride 3 mg/1Tablet, Film coatedOralCoupler LLC67046-1490
RopiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6373
RopiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6374
Ropinirole HydrochlorideRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0727
Ropinirole HydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8188
RopiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-032
RopiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-030
RopiniroleRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-031
RopiniroleRopinirole hydrochloride 5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-036
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-033

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