NDC codes

FDA NDC Directory
Product NDC (as listed)0904-6374Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00904-6374Add 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
0904-6374-610090463746100904637461100 BLISTER PACK in 1 CARTON (0904-6374-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Oct 1, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 1 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Major PharmaceuticalsNDC labeler code 0904
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 0904-6374_5ebf9666-159a-4aee-a889-dc1ab6f104b2SPL ID 5ebf9666-159a-4aee-a889-dc1ab6f104b2SPL set ID e7ef58c0-73ba-4af2-b82b-a33954ec44dfRxCUI 312845, 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

N400904637461 followed by a unit qualifier and the quantity

Package 00904-6374-61. 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)

About NDC 0904-6374

What is NDC 0904-6374?
0904-6374 is the product NDC for Ropinirole, Ropinirole hydrochloride 1 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ropinirole.
What is the active ingredient?
Ropinirole hydrochloride.
Who is the labeler?
Major Pharmaceuticals, NDC labeler code 0904. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ropinirole?
110 other product NDCs are listed under this name. See all Ropinirole NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ropinirole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ropiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-413868788-4138-03
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260272162-2602-0372162-2602-09
RopiniroleRopinirole hydrochloride 4 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260372162-2603-0372162-2603-09
RopiniroleRopinirole hydrochloride 6 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260472162-2604-0372162-2604-09
RopiniroleRopinirole hydrochloride 8 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260572162-2605-0372162-2605-09
RopiniroleRopinirole hydrochloride 12 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-260672162-2606-0372162-2606-09
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Extended releaseOralElite Laboratories, Inc.64850-25064850-0250-30
RopiniroleRopinirole hydrochloride 4 mg/1Tablet, Extended releaseOralElite Laboratories, Inc.64850-25164850-0251-30
RopiniroleRopinirole hydrochloride 6 mg/1Tablet, Extended releaseOralElite Laboratories, Inc.64850-25264850-0252-30
RopiniroleRopinirole hydrochloride 8 mg/1Tablet, Extended releaseOralElite Laboratories, Inc.64850-25364850-0253-30

All 111 Ropinirole NDCs

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 .25 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6373
RopiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-030
RopiniroleRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-031
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
RopiniroleRopinirole hydrochloride 5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Limited46708-036
RopiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7633
RopiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7888
RopiniroleRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-030
RopiniroleRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-031
RopiniroleRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-032
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-033
RopiniroleRopinirole hydrochloride 3 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-034
RopiniroleRopinirole hydrochloride 4 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-035
RopiniroleRopinirole hydrochloride 5 mg/1Tablet, Film coatedOralAlembic Pharmaceuticals Inc.62332-036
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralCoupler LLC67046-1489
RopiniroleRopinirole hydrochloride 3 mg/1Tablet, Film coatedOralCoupler LLC67046-1490
Ropinirole HydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8188

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