Prescription drug · ANDA

ropinirole hydrochloride NDC 43547-268

Ropinirole hydrochloride .25 mg/1 · Tablet, Film coated · Oral · SOLCO HEALTHCARE US, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)43547-268Labeler and product segments. Claims need a package NDC.
Product NDC at billing width43547-0268Add 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
43547-268-104354702681043547026810100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-268-10)Marketed from Sep 20, 2011
43547-268-504354702685043547026850500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-268-50)Marketed from Sep 20, 2011

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 — .25 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
SOLCO HEALTHCARE US, LLCNDC labeler code 43547
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078110
Marketing start
Listing expires
Other FDA classes
Dopamine Agonists (Mechanism)
Identifiers
Product ID 43547-268_0e04048a-c22c-4c6b-9c00-91906541a95aSPL ID 0e04048a-c22c-4c6b-9c00-91906541a95aSPL set ID 7734ef0b-584f-42dd-a8b5-adbdf4e4df93RxCUI 283858, 312845, 312846, 312847, 312849, 314208, 562704UNII D7ZD41RZI9UPC 0343547274108, 0343547271107, 0343547269104, 0343547270100, 0343547272104, 0343547273101, 0343547268107
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

N443547026810 followed by a unit qualifier and the quantity

Package 43547-0268-10. 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 43547-268

What is NDC 43547-268?
43547-268 is the product NDC for ropinirole hydrochloride, Ropinirole hydrochloride .25 mg/1 tablet, film coated, listed with the FDA by SOLCO HEALTHCARE US, LLC. It has 2 package NDCs, 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?
SOLCO HEALTHCARE US, LLC, NDC labeler code 43547. 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 078110

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

FDA NDC Directory listings under ANDA 078110
ProductStrengthForm · routeLabelerProduct NDC
ropinirole hydrochlorideRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-269
ropinirole hydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-270
ropinirole hydrochlorideRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-271
ropinirole hydrochlorideRopinirole hydrochloride 3 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-272
ropinirole hydrochlorideRopinirole hydrochloride 4 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-273
ropinirole hydrochlorideRopinirole hydrochloride 5 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-274
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-595
ropinirole hydrochlorideRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-596
ropinirole hydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-597
ropinirole hydrochlorideRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-598
ropinirole hydrochlorideRopinirole hydrochloride 3 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-599
ropinirole hydrochlorideRopinirole hydrochloride 4 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-600
ropinirole hydrochlorideRopinirole hydrochloride 5 mg/1Tablet, Film coatedOralSOLCO HEALTHCARE US, LLC43547-601
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1330
ropinirole hydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-4348
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralAvPAK50268-741
ropinirole hydrochlorideRopinirole hydrochloride .5 mg/1Tablet, Film coatedOralAvPAK50268-742
ropinirole hydrochlorideRopinirole hydrochloride 1 mg/1Tablet, Film coatedOralAvPAK50268-743
ropinirole hydrochlorideRopinirole hydrochloride 2 mg/1Tablet, Film coatedOralAvPAK50268-744
ropinirole hydrochlorideRopinirole hydrochloride .25 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-360

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