Entacapone NDC 64980-722

NDC codes

FDA NDC Directory

Product NDC (as listed)64980-722Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64980-0722Add 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
64980-722-01	64980072201	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64980-722-01)Marketed from Apr 23, 2026

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): Entacapone
Generic name (nonproprietary): entacapone
Active ingredients: Entacapone — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 206669
Marketing start: Apr 23, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Catechol O-Methyltransferase Inhibitors (Mechanism)
Identifiers: Product ID 64980-722_4f769e67-7f18-2066-e063-6294a90a0a99SPL ID 4f769e67-7f18-2066-e063-6294a90a0a99SPL set ID ee02a04a-4b42-4cfa-8d9d-b1459c0ee9fdRxCUI 317094UNII 4975G9NM6TUPC 0364980722018
Pharmacologic class: 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

N464980072201 followed by a unit qualifier and the quantity

Package 64980-0722-01. 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

Current FDA label (SPL), effective Feb 16, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE Entacapone tablets USP are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose "wearing-off" in patients with Parkinson's disease (see CLINICAL PHARMACOLOGY, Clinical Studies ). Entacapone's effectiveness has not been systematically evaluated in patients with Parkinson's disease who do not experience end-of-dose "wearing-off".

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 206669

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

FDA NDC Directory listings under ANDA 206669
Product	Strength	Form · route	Labeler	Product NDC
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	Lannett Company, Inc.	0527-1830