What is NDC 65862-654?

65862-654 is the product NDC for Entacapone, Entacapone 200 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Entacapone?

13 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Entacapone NDC 65862-654 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-654Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0654Add 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
65862-654-01	65862065401	100 TABLET, FILM COATED in 1 BOTTLE (65862-654-01)Marketed from Jun 19, 2015
65862-654-99	65862065499	1000 TABLET, FILM COATED in 1 BOTTLE (65862-654-99)Marketed from Jun 19, 2015

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: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203437
Marketing start: Jun 19, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Catechol O-Methyltransferase Inhibitors (Mechanism)
Identifiers: Product ID 65862-654_54466878-6cce-44e7-8188-27b6091a5d15SPL ID 54466878-6cce-44e7-8188-27b6091a5d15SPL set ID d9cc1327-5474-4136-970a-ec40c41975b2RxCUI 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

N465862065401 followed by a unit qualifier and the quantity

Package 65862-0654-01. 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 May 9, 2024.

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)

About NDC 65862-654

What is NDC 65862-654?: 65862-654 is the product NDC for Entacapone, Entacapone 200 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Entacapone.
What is the active ingredient?: Entacapone.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Entacapone?: 13 other product NDCs are listed under this name. See all Entacapone 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 Entacapone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	64980-722	64980-0722-01
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-478	62332-0478-3162332-0478-91
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-478	46708-0478-3146708-0478-91
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	Lannett Company, Inc.	0527-1830	00527-1830-37
Entacapone	Entacapone 200 mg/1	TabletOral	Ajanta Pharma USA Inc.	27241-049	27241-0049-10
Entacapone	Entacapone 200 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8298	00615-8298-39
Entacapone	Entacapone 200 mg/1	TabletOral	Macleods Pharmaceuticals Limited	33342-260	33342-0260-1133342-0260-15
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	AvPAK	50268-295	50268-0295-15
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-188	60687-0188-21
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6822	00904-6822-07

All 14 Entacapone NDCs

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	AvPAK	50268-295
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6822
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-188