SINEMET

Product NDC: 78206-167
11-digit product format: 782060167
Labeler code: 78206
Product ID: 78206-167_6c5fd48a-693a-442c-b0f9-80da97b467e9
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
Marketing end: 0000-00-00
Substance: CARBIDOPA; LEVODOPA
Active strength: 25 mg/1; mg/1
Pharmacologic classes: Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	78206-167		D	Discontinued by firm		2026-10-16
excluded package	package	78206-167	78206-167-01	D	Discontinued by firm		2026-10-16

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
N017555-001	SINEMET	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017555-002	SINEMET	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982
N017555-003	SINEMET	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N017555-001	AB
N017555-002	AB
N017555-003	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N017555-003	SINEMET	25MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017555-001	SINEMET	10MG;100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N017555-002	SINEMET	25MG;250MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N017555-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017555-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017555-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017555-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017555-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017555-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017555-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017555-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017555-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017555-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017555-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017555-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017555-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017555-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017555-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017555-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017555-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017555-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017555-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017555-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017555-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017555-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017555-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017555-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017555-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017555-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017555-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017555-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017555-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017555-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017555-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017555-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017555-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017555-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017555-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017555-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017555-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017555-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017555-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017555-001	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ce6fab2-d006-4589-8ba0-02cee499cc60	Product name	2	20260128
ebf3b793-6fcd-797b-9d2e-c3faf6d29442	Product name	5	20251106
162160fe-5ea6-4f9d-aa38-c4b780c57046	Product name	1	20250515
0e5ae331-9620-4d1f-8061-7c437c7f1c42	Product name	1	20250312
028fdaca-77da-0dfe-e445-7dfc440fc97e	Product name	4	20250224
7d015b89-35e8-b484-e5db-c0c44814f63c	Product name	7	20241218
de702a02-e9c0-4daf-9101-e44f2c0d4e66	Product name	1	20220609
681917df-580c-4199-896d-b739fbb25ed3	Product name	1	20190412
7d015b89-35e8-b484-e5db-c0c44814f63c	Product name	4	20171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41	Product name	1	20150313
88839c8d-b65b-4a50-997b-4c74539855ff	Product name	1	20150313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78206-167-01	SINEMET	100 in 1 BOTTLE	TABLET	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78206-167	SINEMET (CARBIDOPA AND LEVODOPA) TABLET [ORGANON LLC]	3	Legacy NDC, 1 package rows	20250228_9b17b028-964a-473c-823d-81423535bd66.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SINEMET	CARBIDOPA AND LEVODOPA	Organon LLC	9b17b028-964a-473c-823d-81423535bd66	2026-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017555 application number: NDA017555 ndc (product): 78206-167

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MNX7R8C5VO	CARBIDOPA	38821-49-7	CARBIDOPA
46627O600J	LEVODOPA	59-92-7	LEVODOPA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197443	carbidopa 10 MG / levodopa 100 MG Oral Tablet	PSN	9b17b028-964a-473c-823d-81423535bd66	5
197444	carbidopa 25 MG / levodopa 100 MG Oral Tablet	PSN	9b17b028-964a-473c-823d-81423535bd66	5
197445	carbidopa 25 MG / levodopa 250 MG Oral Tablet	PSN	9b17b028-964a-473c-823d-81423535bd66	5
724606	SINEMET 10 MG / 100 MG Oral Tablet	PSN	9b17b028-964a-473c-823d-81423535bd66	5
724598	Sinemet 25 MG / 100 MG Oral Tablet	PSN	9b17b028-964a-473c-823d-81423535bd66	5
724602	Sinemet 25 MG / 250 MG Oral Tablet	PSN	9b17b028-964a-473c-823d-81423535bd66	5
724606	carbidopa 10 MG / levodopa 100 MG Oral Tablet [Sinemet]	SBD	9b17b028-964a-473c-823d-81423535bd66	5
724598	carbidopa 25 MG / levodopa 100 MG Oral Tablet [Sinemet]	SBD	9b17b028-964a-473c-823d-81423535bd66	5
724602	carbidopa 25 MG / levodopa 250 MG Oral Tablet [Sinemet]	SBD	9b17b028-964a-473c-823d-81423535bd66	5
197443	carbidopa 10 MG / levodopa 100 MG Oral Tablet	SCD	9b17b028-964a-473c-823d-81423535bd66	5
197444	carbidopa 25 MG / levodopa 100 MG Oral Tablet	SCD	9b17b028-964a-473c-823d-81423535bd66	5
197445	carbidopa 25 MG / levodopa 250 MG Oral Tablet	SCD	9b17b028-964a-473c-823d-81423535bd66	5
197443	carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral Tablet	SY	9b17b028-964a-473c-823d-81423535bd66	5
197444	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral Tablet	SY	9b17b028-964a-473c-823d-81423535bd66	5
197445	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral Tablet	SY	9b17b028-964a-473c-823d-81423535bd66	5
197443	Carbidopa 10 MG / L-DOPA 100 MG Oral Tablet	SY	9b17b028-964a-473c-823d-81423535bd66	5
724606	Carbidopa 10 MG / L-DOPA 100 MG Oral Tablet [Sinemet]	SY	9b17b028-964a-473c-823d-81423535bd66	5
197444	Carbidopa 25 MG / L-DOPA 100 MG Oral Tablet	SY	9b17b028-964a-473c-823d-81423535bd66	5
724598	Carbidopa 25 MG / L-DOPA 100 MG Oral Tablet [Sinemet]	SY	9b17b028-964a-473c-823d-81423535bd66	5
197445	Carbidopa 25 MG / L-DOPA 250 MG Oral Tablet	SY	9b17b028-964a-473c-823d-81423535bd66	5
724602	Carbidopa 25 MG / L-DOPA 250 MG Oral Tablet [Sinemet]	SY	9b17b028-964a-473c-823d-81423535bd66	5
724606	Sinemet 10-100 (carbidopa / levodopa) Oral Tablet	SY	9b17b028-964a-473c-823d-81423535bd66	5
724606	Sinemet 10/100 Oral Tablet	SY	9b17b028-964a-473c-823d-81423535bd66	5
724598	Sinemet 25-100 (carbidopa / levodopa) Oral Tablet	SY	9b17b028-964a-473c-823d-81423535bd66	5
724598	Sinemet 25-100 Oral Tablet	SY	9b17b028-964a-473c-823d-81423535bd66	5
724602	Sinemet 25-250 (carbidopa / levodopa) Oral Tablet	SY	9b17b028-964a-473c-823d-81423535bd66	5
724602	Sinemet 25/250 Oral Tablet	SY	9b17b028-964a-473c-823d-81423535bd66	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78206-167-01	78206016701	100 TABLET in 1 BOTTLE (78206-167-01)	100 tablet	2021-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SINEMET ® (carbidopa and levodopa) Tablets	Organon LLC	2026-08-01	HUMAN PRESCRIPTION DRUG LABEL	6