NDC codes

FDA NDC Directory
Product NDC (as listed)42291-715Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42291-0715Add 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
42291-715-30422910715304229107153030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42291-715-30)Marketed from Nov 1, 2023

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 Hydrochloride
Generic name (nonproprietary)
ropinirole hydrochloride
Active ingredients
Ropinirole hydrochloride — 6 mg/1
Dosage form
Tablet, Film coated, Extended release
Route
Oral
Labeler
AvKARENDC labeler code 42291
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090869
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 42291-715_2b47ad1c-e1cb-7b8b-e063-6394a90aee3cSPL ID 2b47ad1c-e1cb-7b8b-e063-6394a90aee3cSPL set ID abd344d9-7635-62a2-d4e1-38fc46937397RxCUI 799054, 799055, 799056, 824959, 848582UNII D7ZD41RZI9UPC 0342291716308, 0342291717305, 0342291714304, 0342291715301, 0342291713307
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

N442291071530 followed by a unit qualifier and the quantity

Package 42291-0715-30. 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)

About NDC 42291-715

What is NDC 42291-715?
42291-715 is the product NDC for Ropinirole Hydrochloride, Ropinirole hydrochloride 6 mg/1 tablet, film coated, extended release, listed with the FDA by AvKARE. 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?
AvKARE, NDC labeler code 42291. 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 .25 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-818800615-8188-39
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

All 38 Ropinirole Hydrochloride NDCs

Other NDCs under ANDA 090869

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

FDA NDC Directory listings under ANDA 090869
ProductStrengthForm · routeLabelerProduct NDC
RopiniroleRopinirole hydrochloride 6 mg/1Tablet, Film coated, Extended releaseOralActavis Pharma, Inc.0228-3640
RopiniroleRopinirole hydrochloride 2 mg/1Tablet, Film coated, Extended releaseOralActavis Pharma, Inc.0228-3658
RopiniroleRopinirole hydrochloride 4 mg/1Tablet, Film coated, Extended releaseOralActavis Pharma, Inc.0228-3659
RopiniroleRopinirole hydrochloride 8 mg/1Tablet, Film coated, Extended releaseOralActavis Pharma, Inc.0228-3660
RopiniroleRopinirole hydrochloride 12 mg/1Tablet, Film coated, Extended releaseOralActavis Pharma, Inc.0228-3661
Ropinirole HydrochlorideRopinirole hydrochloride 2 mg/1Tablet, Film coated, Extended releaseOralAvKARE42291-713
Ropinirole HydrochlorideRopinirole hydrochloride 4 mg/1Tablet, Film coated, Extended releaseOralAvKARE42291-714
Ropinirole HydrochlorideRopinirole hydrochloride 8 mg/1Tablet, Film coated, Extended releaseOralAvKARE42291-716
Ropinirole HydrochlorideRopinirole hydrochloride 12 mg/1Tablet, Film coated, Extended releaseOralAvKARE42291-717

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