FDA.reportPublic FDA data

SINEMET

Product NDC
78206-166
11-digit product format
782060166
Labeler code
78206
Product ID
78206-166_554f49ca-861e-4511-a54d-18c23d0ecbf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
carbidopa and levodopa
Dosage form
TABLET
Route
ORAL
Labeler
Organon LLC
Application
NDA017555
Marketing category
NDA
Marketing start
2021-06-01
Substance
CARBIDOPA; LEVODOPA
Active strength
10; 100 mg/1; mg/1
Pharmacologic classes
Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SINEMET
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARBIDOPA10 mg/1
LEVODOPA100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMNX7R8C5VO, 46627O600J
Rxcui197443, 197444, 197445, 724598, 724602, 724606

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ce6fab2-d006-4589-8ba0-02cee499cc60Product name220260128
ebf3b793-6fcd-797b-9d2e-c3faf6d29442Product name520251106
162160fe-5ea6-4f9d-aa38-c4b780c57046Product name120250515
0e5ae331-9620-4d1f-8061-7c437c7f1c42Product name120250312
028fdaca-77da-0dfe-e445-7dfc440fc97eProduct name420250224
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name720241218
de702a02-e9c0-4daf-9101-e44f2c0d4e66Product name120220609
681917df-580c-4199-896d-b739fbb25ed3Product name120190412
7d015b89-35e8-b484-e5db-c0c44814f63cProduct name420171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41Product name120150313
88839c8d-b65b-4a50-997b-4c74539855ffProduct name120150313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-166-01SINEMET100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-166-01EA - Each78206-1664e7e699d-696f-4f15-b3f3-27d9722830a912021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-166SINEMET (CARBIDOPA AND LEVODOPA) TABLET [ORGANON LLC]3Current NDC, Legacy NDC, 1 package rows20250228_9b17b028-964a-473c-823d-81423535bd66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197443carbidopa 10 MG / levodopa 100 MG Oral TabletPSN9b17b028-964a-473c-823d-81423535bd665
197444carbidopa 25 MG / levodopa 100 MG Oral TabletPSN9b17b028-964a-473c-823d-81423535bd665
197445carbidopa 25 MG / levodopa 250 MG Oral TabletPSN9b17b028-964a-473c-823d-81423535bd665
724606SINEMET 10 MG / 100 MG Oral TabletPSN9b17b028-964a-473c-823d-81423535bd665
724598Sinemet 25 MG / 100 MG Oral TabletPSN9b17b028-964a-473c-823d-81423535bd665
724602Sinemet 25 MG / 250 MG Oral TabletPSN9b17b028-964a-473c-823d-81423535bd665
724606carbidopa 10 MG / levodopa 100 MG Oral Tablet [Sinemet]SBD9b17b028-964a-473c-823d-81423535bd665
724598carbidopa 25 MG / levodopa 100 MG Oral Tablet [Sinemet]SBD9b17b028-964a-473c-823d-81423535bd665
724602carbidopa 25 MG / levodopa 250 MG Oral Tablet [Sinemet]SBD9b17b028-964a-473c-823d-81423535bd665
197443carbidopa 10 MG / levodopa 100 MG Oral TabletSCD9b17b028-964a-473c-823d-81423535bd665
197444carbidopa 25 MG / levodopa 100 MG Oral TabletSCD9b17b028-964a-473c-823d-81423535bd665
197445carbidopa 25 MG / levodopa 250 MG Oral TabletSCD9b17b028-964a-473c-823d-81423535bd665
197443carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral TabletSY9b17b028-964a-473c-823d-81423535bd665
197444carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral TabletSY9b17b028-964a-473c-823d-81423535bd665
197445carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral TabletSY9b17b028-964a-473c-823d-81423535bd665
197443Carbidopa 10 MG / L-DOPA 100 MG Oral TabletSY9b17b028-964a-473c-823d-81423535bd665
724606Carbidopa 10 MG / L-DOPA 100 MG Oral Tablet [Sinemet]SY9b17b028-964a-473c-823d-81423535bd665
197444Carbidopa 25 MG / L-DOPA 100 MG Oral TabletSY9b17b028-964a-473c-823d-81423535bd665
724598Carbidopa 25 MG / L-DOPA 100 MG Oral Tablet [Sinemet]SY9b17b028-964a-473c-823d-81423535bd665
197445Carbidopa 25 MG / L-DOPA 250 MG Oral TabletSY9b17b028-964a-473c-823d-81423535bd665
724602Carbidopa 25 MG / L-DOPA 250 MG Oral Tablet [Sinemet]SY9b17b028-964a-473c-823d-81423535bd665
724606Sinemet 10-100 (carbidopa / levodopa) Oral TabletSY9b17b028-964a-473c-823d-81423535bd665
724606Sinemet 10/100 Oral TabletSY9b17b028-964a-473c-823d-81423535bd665
724598Sinemet 25-100 (carbidopa / levodopa) Oral TabletSY9b17b028-964a-473c-823d-81423535bd665
724598Sinemet 25-100 Oral TabletSY9b17b028-964a-473c-823d-81423535bd665
724602Sinemet 25-250 (carbidopa / levodopa) Oral TabletSY9b17b028-964a-473c-823d-81423535bd665
724602Sinemet 25/250 Oral TabletSY9b17b028-964a-473c-823d-81423535bd665

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78206-166-0178206016601100 TABLET in 1 BOTTLE (78206-166-01) 100 tablet2021-06-010000-00-00NoNoCurrent