What is NDC 0228-3640?

0228-3640 is the product NDC for Ropinirole, Ropinirole hydrochloride 6 mg/1 tablet, film coated, extended release, listed with the FDA by Actavis Pharma, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Actavis Pharma, Inc., NDC labeler code 0228. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ropinirole NDC 0228-3640 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0228-3640Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00228-3640Add 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 NDC	11-digit (billing)	Package	Copy
0228-3640-03	0022836400300228364003	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0228-3640-03)Marketed from Aug 23, 2012

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 — 6 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Actavis Pharma, Inc.NDC labeler code 0228
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090869
Marketing start: Aug 23, 2012
Listing expires: Dec 31, 2026
Other FDA classes: Dopamine Agonists (Mechanism)
Identifiers: Product ID 0228-3640_3499549d-d3ad-4636-8234-2539c0fbfac1SPL ID 3499549d-d3ad-4636-8234-2539c0fbfac1SPL set ID 300946bf-2f83-471d-868d-9820b65c52bbRxCUI 799054, 799055, 799056, 824959, 848582UNII 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

N400228364003 followed by a unit qualifier and the quantity

Package 00228-3640-03. 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 Aug 1, 2023.

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 0228-3640

What is NDC 0228-3640?: 0228-3640 is the product NDC for Ropinirole, Ropinirole hydrochloride 6 mg/1 tablet, film coated, extended release, listed with the FDA by Actavis Pharma, Inc.. 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?: Actavis Pharma, Inc., NDC labeler code 0228. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
ropinirole	Ropinirole hydrochloride 2 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4138	68788-4138-03
Ropinirole	Ropinirole hydrochloride 2 mg/1	Tablet, Extended releaseOral	Elite Laboratories, Inc.	64850-250	64850-0250-30
Ropinirole	Ropinirole hydrochloride 4 mg/1	Tablet, Extended releaseOral	Elite Laboratories, Inc.	64850-251	64850-0251-30
Ropinirole	Ropinirole hydrochloride 6 mg/1	Tablet, Extended releaseOral	Elite Laboratories, Inc.	64850-252	64850-0252-30
Ropinirole	Ropinirole hydrochloride 8 mg/1	Tablet, Extended releaseOral	Elite Laboratories, Inc.	64850-253	64850-0253-30
Ropinirole	Ropinirole hydrochloride 12 mg/1	Tablet, Extended releaseOral	Elite Laboratories, Inc.	64850-254	64850-0254-30
Ropinirole	Ropinirole hydrochloride 2 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2602	72162-2602-0372162-2602-09
Ropinirole	Ropinirole hydrochloride 4 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2603	72162-2603-0372162-2603-09
Ropinirole	Ropinirole hydrochloride 6 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2604	72162-2604-0372162-2604-09
Ropinirole	Ropinirole hydrochloride 8 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2605	72162-2605-0372162-2605-09

All 111 Ropinirole 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
Product	Strength	Form · route	Labeler	Product NDC
Ropinirole	Ropinirole hydrochloride 2 mg/1	Tablet, Film coated, Extended releaseOral	Actavis Pharma, Inc.	0228-3658
Ropinirole	Ropinirole hydrochloride 4 mg/1	Tablet, Film coated, Extended releaseOral	Actavis Pharma, Inc.	0228-3659
Ropinirole	Ropinirole hydrochloride 8 mg/1	Tablet, Film coated, Extended releaseOral	Actavis Pharma, Inc.	0228-3660
Ropinirole	Ropinirole hydrochloride 12 mg/1	Tablet, Film coated, Extended releaseOral	Actavis Pharma, Inc.	0228-3661
Ropinirole Hydrochloride	Ropinirole hydrochloride 2 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-713
Ropinirole Hydrochloride	Ropinirole hydrochloride 4 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-714
Ropinirole Hydrochloride	Ropinirole hydrochloride 6 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-715
Ropinirole Hydrochloride	Ropinirole hydrochloride 8 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-716
Ropinirole Hydrochloride	Ropinirole hydrochloride 12 mg/1	Tablet, Film coated, Extended releaseOral	AvKARE	42291-717