What is NDC 0781-5578?

0781-5578 is the product NDC for Entacapone, Entacapone 200 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. 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 0781-5578 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-5578Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-5578Add 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
0781-5578-01	00781557801	100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01)Marketed from Jun 4, 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): Entacapone
Generic name (nonproprietary): entacapone
Active ingredients: Entacapone — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020796
Marketing start: Jun 4, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Catechol O-Methyltransferase Inhibitors (Mechanism)
Identifiers: Product ID 0781-5578_a5584d62-a95a-4a17-8c37-0f0bc72b9bb5SPL ID a5584d62-a95a-4a17-8c37-0f0bc72b9bb5SPL set ID ad4b6d79-efd3-4c43-b4dc-5afdacf939a4RxCUI 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

N400781557801 followed by a unit qualifier and the quantity

Package 00781-5578-01. 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 Nov 30, 2023.

Indications (excerpt from the label)

INDICATIONS Entacapone tablets 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 tablet’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)

About NDC 0781-5578

What is NDC 0781-5578?: 0781-5578 is the product NDC for Entacapone, Entacapone 200 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 1 package NDC, 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?: Sandoz Inc, NDC labeler code 0781. 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	Macleods Pharmaceuticals Limited	33342-260	33342-0260-1133342-0260-15
Entacapone	Entacapone 200 mg/1	TabletOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8298	00615-8298-39
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 NDA 020796

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

FDA NDC Directory listings under NDA 020796
Product	Strength	Form · route	Labeler	Product NDC
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-247
Entacapone	Entacapone 200 mg/1	Tablet, Film coatedOral	Sun Pharmaceutical Industries, Inc.	47335-007