Prescription drug · NDA
Sinemet (Carbidopa and levodopa) NDC 78206-166
Carbidopa 10 mg/1; Levodopa 100 mg/1 · Tablet · Oral · Organon LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 78206-166-01 | 7820601660178206016601 | 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
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Organon LLCNDC labeler code 78206
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017555
- Marketing start
- Listing expires
- 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 MNX7R8C5VO, 46627O600JUPC 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
N478206016601followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 78206-166
- What is NDC 78206-166?
- 78206-166 is the product NDC for Sinemet, Carbidopa 10 mg/1; Levodopa 100 mg/1 tablet, listed with the FDA by Organon LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sinemet (Carbidopa and levodopa).
- What is the active ingredient?
- Carbidopa, Levodopa.
- Who is the labeler?
- Organon LLC, NDC labeler code 78206. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sinemet?
- 1 other product NDC are listed under this name. See all Sinemet NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sinemet products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sinemetcarbidopa and levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | Organon LLC | 78206-190 | 78206-0190-01 |
Other NDCs under NDA 017555
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sinemetcarbidopa and levodopa | Carbidopa 25 mg/1; Levodopa 100 mg/1 | TabletOral | Organon LLC | 78206-190 |