Carbidopa, Levodopa and Entacapone NDC 33342-496

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-496Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0496Add 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
33342-496-11	33342049611	100 TABLET, FILM COATED in 1 BOTTLE (33342-496-11)Marketed from Apr 15, 2025
33342-496-12	33342049612	10 BLISTER PACK in 1 CARTON (33342-496-12) / 10 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Apr 15, 2025

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): Carbidopa, Levodopa and Entacapone
Generic name (nonproprietary): carbidopa, levodopa and entacapone
Active ingredients: Carbidopa — 50 mg/1Levodopa — 200 mg/1Entacapone — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Macleods Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214495
Marketing start: Apr 15, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Aromatic (Chemical structure)Catechol O-Methyltransferase Inhibitors (Mechanism)
Identifiers: Product ID 33342-496_ab41796a-b051-41fa-b8ee-e88b9236931aSPL ID ab41796a-b051-41fa-b8ee-e88b9236931aSPL set ID f0d9d7a8-1d06-4119-b2bc-42b3ec08d45bRxCUI 403850, 403851, 403852, 730988, 810083, 810090UNII 46627O600J, MNX7R8C5VO, 4975G9NM6TUPC 0333342491121, 0333342496119, 0333342492128, 0333342496126, 0333342491114, 0333342493125, 0333342495112, 0333342493118, 0333342495129, 0333342492111, 0333342494122, 0333342494115
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

N433342049611 followed by a unit qualifier and the quantity

Package 33342-0496-11. 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 Apr 8, 2026.

Indications (excerpt from the label)

Carbidopa, levodopa and entacapone tablets, is 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 (aromatic …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214495

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

FDA NDC Directory listings under ANDA 214495
Product	Strength	Form · route	Labeler	Product NDC
Carbidopa, Levodopa and Entacapone	Carbidopa 12.5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-491
Carbidopa, Levodopa and Entacapone	Carbidopa 37.5 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-495
Carbidopa, Levodopa and Entacapone	Carbidopa 18.75 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-492
Carbidopa, Levodopa and Entacapone	Carbidopa 25 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-493
Carbidopa, Levodopa and Entacapone	Carbidopa 31.25 mg/1 + 2 more ingredients	Tablet, Film coatedOral	Macleods Pharmaceuticals Limited	33342-494