Sinemet NDC 78206-166

NDC codes

FDA NDC Directory

Product NDC (as listed)78206-166Labeler and product segments. Claims need a package NDC.

Product NDC at billing width78206-0166Add 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
78206-166-01	78206016601	100 TABLET in 1 BOTTLE (78206-166-01)Marketed from Jun 1, 2021

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): Sinemet
Generic name (nonproprietary): carbidopa and levodopa
Active ingredients: Carbidopa — 10 mg/1Levodopa — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Organon LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 017555
Marketing start: Jun 1, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Aromatic (Chemical structure)
Identifiers: Product ID 78206-166_60aaac4b-58e7-485c-9f27-95fcc35b5c48SPL ID 60aaac4b-58e7-485c-9f27-95fcc35b5c48SPL set ID 9b17b028-964a-473c-823d-81423535bd66RxCUI 197443, 197444, 197445, 724598, 724602, 724606UNII 46627O600J, MNX7R8C5VOUPC 0378206168016, 0378206190017, 0378206167019, 0378206166012
Pharmacologic class: Aromatic Amino Acid

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

N478206016601 followed by a unit qualifier and the quantity

Package 78206-0166-01. 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 Aug 1, 2026.

Indications (excerpt from the label)

INDICATIONS AND USAGE SINEMET is indicated in the treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism that may follow carbon monoxide intoxication or manganese intoxication. Carbidopa allows patients treated for Parkinson's disease to use much lower doses of levodopa. Some patients who responded poorly to levodopa have improved on SINEMET. This is most likely due to decreased peripheral decarboxylation of levodopa caused by administration of carbidopa rather than by a primary effect of carbidopa on the nervous system. Carbidopa has not been shown to enhance the intrinsic efficacy of levodopa. Carbidopa may also reduce nausea and vomiting and permit …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 017555

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

FDA NDC Directory listings under NDA 017555
Product	Strength	Form · route	Labeler	Product NDC
Sinemetcarbidopa and levodopa	Carbidopa 25 mg/1; Levodopa 100 mg/1	TabletOral	Organon LLC	78206-190