Prescription drug · ANDA

Ropinirole Hydrochloride NDC 0615-8188

Ropinirole hydrochloride .25 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs

NDC codes

FDA NDC Directory
Product NDC (as listed)0615-8188Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00615-8188Add 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
0615-8188-39006158188390061581883930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8188-39)Marketed from Mar 5, 2018

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 Hydrochloride
Generic name (nonproprietary)
ropinirole hydrochloride
Active ingredients
Ropinirole hydrochloride — .25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
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 0615-8188_76b08d6e-992e-4f34-b803-7ed84025a75fSPL ID 76b08d6e-992e-4f34-b803-7ed84025a75fSPL set ID 48a63d7e-c0af-4b09-863c-2af7beb2e80fRxCUI 312845, 312846, 312847, 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

N400615818839 followed by a unit qualifier and the quantity

Package 00615-8188-39. 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 areindicated for the treatment of Parkinson’s disease. 1.2 Restless Legs Syndrome Ropinirole tablets areindicated 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 0615-8188

What is NDC 0615-8188?
0615-8188 is the product NDC for Ropinirole Hydrochloride, Ropinirole hydrochloride .25 mg/1 tablet, film coated, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ropinirole Hydrochloride.
What is the active ingredient?
Ropinirole hydrochloride.
Who is the labeler?
NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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 Hydrochloride?
37 other product NDCs are listed under this name. See all Ropinirole Hydrochloride 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 Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralAvPAK50268-74150268-0741-15
ropinirole hydrochlorideRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralAvPAK50268-74250268-0742-15
ropinirole hydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralAvPAK50268-74350268-0743-15
ropinirole hydrochlorideRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralAvPAK50268-74450268-0744-15
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-57760687-0577-01
ropinirole hydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-58860687-0588-01
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-36051655-0360-26
Ropinirole HydrochlorideRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-818900615-8189-39
Ropinirole HydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-819000615-8190-39
Ropinirole HydrochlorideRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-819100615-8191-39

All 38 Ropinirole Hydrochloride 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 1 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6374
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

Showing 20 of 25.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in