What is NDC 46708-264?

46708-264 is the product NDC for Ropinirole, Ropinirole hydrochloride 6 mg/1 tablet, film coated, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-264 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-264Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0264Add 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
46708-264-10	4670802641046708026410	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (46708-264-10)Marketed from Mar 14, 2013
46708-264-30	4670802643046708026430	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-30)Marketed from Mar 14, 2013
46708-264-31	4670802643146708026431	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-31)Marketed from Mar 14, 2013
46708-264-71	4670802647146708026471	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-71)Marketed from Mar 14, 2013
46708-264-90	4670802649046708026490	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-90)Marketed from Mar 14, 2013
46708-264-91	4670802649146708026491	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-264-91)Marketed from Mar 14, 2013

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
Generic name (nonproprietary): ropinirole
Active ingredients: Ropinirole hydrochloride — 6 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202786
Marketing start: Mar 14, 2013
Listing expires: Dec 31, 2027
Other FDA classes: Dopamine Agonists (Mechanism)
Identifiers: Product ID 46708-264_a1e5da4e-74fc-4482-8e15-599c665f2c2fSPL ID a1e5da4e-74fc-4482-8e15-599c665f2c2fSPL set ID 2e01dbdd-f439-45d7-9085-2d92a1a1fee2RxCUI 799054, 799055, 799056, 824959, 848582UNII D7ZD41RZI9UPC 0346708263300, 0346708262303, 0346708264307, 0346708265304, 0346708266301
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

N446708026410 followed by a unit qualifier and the quantity

Package 46708-0264-10. 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 Jan 27, 2023.

Indications (excerpt from the label)

Ropinirole extended-release tablets are non-ergoline dopamine agonist indicated for the treatment of Parkinson’s disease (1.1) 1.1 Parkinson's Disease Ropinirole extended-release tablets are indicated for the treatment of Parkinson’s disease.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 46708-264

What is NDC 46708-264?: 46708-264 is the product NDC for Ropinirole, Ropinirole hydrochloride 6 mg/1 tablet, film coated, extended release, listed with the FDA by Alembic Pharmaceuticals Limited. It has 6 package NDCs, 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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	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
Ropinirole	Ropinirole hydrochloride 12 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	72162-2606	72162-2606-0372162-2606-09
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

All 111 Ropinirole NDCs

Other NDCs under ANDA 202786

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

FDA NDC Directory listings under ANDA 202786
Product	Strength	Form · route	Labeler	Product NDC
Ropinirole	Ropinirole hydrochloride 2 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-262
Ropinirole	Ropinirole hydrochloride 4 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-263
Ropinirole	Ropinirole hydrochloride 8 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-265
Ropinirole	Ropinirole hydrochloride 12 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-266
Ropinirole	Ropinirole hydrochloride 2 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-107
Ropinirole	Ropinirole hydrochloride 4 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-108
Ropinirole	Ropinirole hydrochloride 6 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-109
Ropinirole	Ropinirole hydrochloride 8 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-110
Ropinirole	Ropinirole hydrochloride 12 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-111