Carbidopa, Levodopa, and Entacapone NDC 0781-5669

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-5669Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-5669Add 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
0781-5669-01	00781566901	100 TABLET, FILM COATED in 1 BOTTLE (0781-5669-01)Marketed from Jun 18, 2014

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): Carbidopa, Levodopa, and Entacapone
Generic name (nonproprietary): carbidopa, levodopa, and entacapone
Active ingredients: Carbidopa — 50 mg/1Levodopa — 200 mg/1Entacapone — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021485
Marketing start: Jun 18, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Aromatic (Chemical structure)Catechol O-Methyltransferase Inhibitors (Mechanism)
Identifiers: Product ID 0781-5669_2176ea25-da6b-47b2-a081-b3da614df0a0SPL ID 2176ea25-da6b-47b2-a081-b3da614df0a0SPL set ID 9c16c0e0-3b97-486b-b7d5-579f5853e2c5RxCUI 403850, 403851, 403852, 730988, 810083, 810090UNII MNX7R8C5VO, 46627O600J, 4975G9NM6TUPC 0307815625016
Pharmacologic class: Aromatic Amino Acid; Catechol-O-Methyltransferase Inhibitor

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

N400781566901 followed by a unit qualifier and the quantity

Package 00781-5669-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 021485

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

FDA NDC Directory listings under NDA 021485
Product	Strength	Form · route	Labeler	Product NDC
Carbidopa, Levodopa, and Entacapone	Carbidopa 12.5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Sandoz Inc	0781-5613
Carbidopa, Levodopa, and Entacapone	Carbidopa 18.75 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Sandoz Inc	0781-5625
Carbidopa, Levodopa, and Entacapone	Carbidopa 25 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Sandoz Inc	0781-5637
Carbidopa, Levodopa, and Entacapone	Carbidopa 31.25 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Sandoz Inc	0781-5641
Carbidopa, Levodopa, and Entacapone	Carbidopa 37.5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Sandoz Inc	0781-5654