Entacapone NDC 50268-295

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-295Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0295Add 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
50268-295-15	50268029515	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-295-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-295-11)Marketed from Dec 5, 2016

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: AvPAK
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203437
Marketing start: Dec 5, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Catechol O-Methyltransferase Inhibitors (Mechanism)
Identifiers: Product ID 50268-295_47e3561c-c311-d3fd-e063-6394a90ae2ccSPL ID 47e3561c-c311-d3fd-e063-6394a90ae2ccSPL set ID 1fab63f2-9257-6998-5658-7e98db51b184RxCUI 317094UNII 4975G9NM6T
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

N450268029515 followed by a unit qualifier and the quantity

Package 50268-0295-15. 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 8, 2026.

Indications (excerpt from the label)

INDICATIONS 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 tablets, USP 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 203437

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

FDA NDC Directory listings under ANDA 203437
Product	Strength	Form · route	Labeler	Product NDC
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-188
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6822
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-654