NDC 78206-168

SINEMET

Carbidopa And Levodopa

SINEMET is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Organon Llc. The primary component is Carbidopa; Levodopa.

Product ID78206-168_9b9c9d89-44ee-48c3-b016-e4c264632c26
NDC78206-168
Product TypeHuman Prescription Drug
Proprietary NameSINEMET
Generic NameCarbidopa And Levodopa
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2021-06-01
Marketing CategoryNDA /
Application NumberNDA017555
Labeler NameOrganon LLC
Substance NameCARBIDOPA; LEVODOPA
Active Ingredient Strength25 mg/1; mg/1
Pharm ClassesAromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 78206-168-01

100 TABLET in 1 BOTTLE (78206-168-01)
Marketing Start Date2021-06-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "SINEMET" or generic name "Carbidopa And Levodopa"

NDCBrand NameGeneric Name
0006-3915SINEMETcarbidopa and levodopa
0006-3916SINEMETcarbidopa and levodopa
0006-3917SINEMETcarbidopa and levodopa
0006-3918SINEMETcarbidopa and levodopa
0006-3919SINEMETcarbidopa and levodopa
0006-6722SINEMETcarbidopa and levodopa
0006-6723SINEMETcarbidopa and levodopa
0006-6724SINEMETcarbidopa and levodopa
0228-2538Carbidopa and levodopaCarbidopa and levodopa
0228-2539Carbidopa and levodopaCarbidopa and levodopa
0228-2540Carbidopa and levodopaCarbidopa and levodopa
0378-0078Carbidopa and Levodopacarbidopa and levodopa
0378-0085Carbidopa and Levodopacarbidopa and levodopa
0378-0088Carbidopa and Levodopacarbidopa and levodopa
0378-0094Carbidopa and Levodopacarbidopa and levodopa
0378-1133Carbidopa and Levodopacarbidopa and levodopa
0378-5051Carbidopa and Levodopacarbidopa and levodopa
0378-5052Carbidopa and Levodopacarbidopa and levodopa
0378-5053Carbidopa and Levodopacarbidopa and levodopa
0615-3537Carbidopa and levodopaCarbidopa and levodopa
0615-3561Carbidopa and levodopaCarbidopa and levodopa
0074-3012DuopaCarbidopa and Levodopa

Trademark Results [SINEMET]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SINEMET
SINEMET
72466217 0979811 Live/Registered
MERCK & CO., INC.
1973-08-21

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.