What is NDC 0781-5613?

0781-5613 is the product NDC for Carbidopa, Levodopa, and Entacapone, Carbidopa 12.5 mg/1 + 2 more ingredients tablet, film coated, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Carbidopa, Levodopa, Entacapone.

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 Carbidopa, Levodopa, and Entacapone?

29 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Carbidopa, Levodopa, and Entacapone NDC 0781-5613

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-5613Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-5613Add 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
0781-5613-01	0078156130100781561301	100 TABLET, FILM COATED in 1 BOTTLE (0781-5613-01)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 — 12.5 mg/1Levodopa — 50 mg/1Entacapone — 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 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 0781-5613_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, 4975G9NM6T, 46627O600JUPC 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

N400781561301 followed by a unit qualifier and the quantity

Package 00781-5613-01. 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 Mar 19, 2026.

Indications (excerpt from the label)

Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease. Carbidopa, levodopa and entacapone tablets can be used: • To substitute (with equivalent strengths of each of the three components) carbidopa/levodopa and entacapone previously administered as individual products. • To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearing-off” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias. Carbidopa, levodopa and entacapone tablets, a combination drug consisting of levodopa (aromatic amino acid), carbidopa (aroma…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-5613

What is NDC 0781-5613?: 0781-5613 is the product NDC for Carbidopa, Levodopa, and Entacapone, Carbidopa 12.5 mg/1 + 2 more ingredients 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?: Carbidopa, Levodopa, and Entacapone.
What is the active ingredient?: Carbidopa, Levodopa, 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 Carbidopa, Levodopa, and Entacapone?: 29 other product NDCs are listed under this name. See all Carbidopa, Levodopa, and 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 Carbidopa, Levodopa, and Entacapone NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
carbidopa, levodopa and entacapone	Carbidopa 12.5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-795	46708-0795-3146708-0795-91
carbidopa, levodopa and entacapone	Carbidopa 18.75 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-796	46708-0796-3146708-0796-91
carbidopa, levodopa and entacapone	Carbidopa 25 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-797	46708-0797-3146708-0797-91
carbidopa, levodopa and entacapone	Carbidopa 31.25 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-798	46708-0798-3146708-0798-91
carbidopa, levodopa and entacapone	Carbidopa 37.5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-799	46708-0799-3146708-0799-91
carbidopa, levodopa and entacapone	Carbidopa 50 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Alembic Pharmaceuticals Limited	46708-800	46708-0800-3146708-0800-91
carbidopa, levodopa and entacapone	Carbidopa 12.5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-795	62332-0795-3162332-0795-91
carbidopa, levodopa and entacapone	Carbidopa 18.75 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-796	62332-0796-3162332-0796-91
carbidopa, levodopa and entacapone	Carbidopa 25 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-797	62332-0797-3162332-0797-91
carbidopa, levodopa and entacapone	Carbidopa 31.25 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Alembic Pharmaceuticals Inc.	62332-798	62332-0798-3162332-0798-91

All 30 Carbidopa, Levodopa, and Entacapone NDCs

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 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
Carbidopa, Levodopa, and Entacapone	Carbidopa 50 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Sandoz Inc	0781-5669