Ropinirole NDC 46708-265

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-265Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0265Add 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
46708-265-10	46708026510	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 CARTON (46708-265-10)Marketed from Mar 14, 2013
46708-265-30	46708026530	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-30)Marketed from Mar 14, 2013
46708-265-31	46708026531	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-31)Marketed from Mar 14, 2013
46708-265-71	46708026571	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-71)Marketed from Mar 14, 2013
46708-265-90	46708026590	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-90)Marketed from Mar 14, 2013
46708-265-91	46708026591	1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (46708-265-91)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 — 8 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Alembic Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202786
Marketing start: Mar 14, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Dopamine Agonists (Mechanism)
Identifiers: Product ID 46708-265_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

N446708026510 followed by a unit qualifier and the quantity

Package 46708-0265-10. 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)

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 6 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Inc.	62332-109
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 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
Ropinirole	Ropinirole hydrochloride 2 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-262
Ropinirole	Ropinirole hydrochloride 12 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-266
Ropinirole	Ropinirole hydrochloride 4 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-263
Ropinirole	Ropinirole hydrochloride 6 mg/1	Tablet, Film coated, Extended releaseOral	Alembic Pharmaceuticals Limited	46708-264