SINEMET

Product NDC: 0006-3918
11-digit product format: 000063918
Labeler code: 0006
Product ID: 0006-3918_a98367b2-6b90-4c23-a521-a9b712752c05
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbidopa and levodopa
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Merck Sharp & Dohme Corp.
Application: NDA019856
Marketing category: NDA
Marketing start: 1991-05-30
Marketing end: 0000-00-00
Substance: CARBIDOPA; LEVODOPA
Active strength: 25 mg/1; mg/1
Pharmacologic classes: Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0006-3918		D	Discontinued by firm		2026-10-23
excluded package	package	0006-3918	0006-3918-68	D	Discontinued by firm		2026-10-23

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0006-3918-68	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0006-3918-68	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0006-3918-68	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0006-3918-68	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0006-3918-68	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0006-3918-68	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0006-3918-68	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0006-3918-68	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0006-3918-68	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0006-3918-68	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0006-3918-68	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0006-3918-68	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019856-001	SINEMET CR	CARBIDOPA; LEVODOPA	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1991-05-30
N019856-002	SINEMET CR	CARBIDOPA; LEVODOPA	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	1992-12-24

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 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019856-001	SINEMET CR	50MG;200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019856-002	SINEMET CR	25MG;100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019856-001	SINEMET CR	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019856-002	SINEMET CR	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019856-001	SINEMET CR	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019856-002	SINEMET CR	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019856-001	SINEMET CR	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-05-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019856-002	SINEMET CR	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1992-12-24	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019856-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N019856-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019856-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N019856-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019856-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N019856-002	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-3918-68	EA - Each	0006-3918	43a18648-2dd7-4bb5-8189-694a89443af6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
carbidopa	ACTIVE INGREDIENT	MNX7R8C5VO	SINEMET CR (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	5
levodopa	ACTIVE INGREDIENT	46627O600J	SINEMET CR (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	5
CARBIDOPA ANHYDROUS	ACTIVE MOIETY	KR87B45RGH	SINEMET CR (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	5
levodopa	ACTIVE MOIETY	46627O600J	SINEMET CR (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	5
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	SINEMET CR (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SINEMET CR (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SINEMET CR (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	SINEMET CR (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	5
HYPROMELLOSE 2208 (3 MPA.S)	INACTIVE INGREDIENT	9H4L916OBU	SINEMET CR (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	5
INDIGOTINDISULFONATE SODIUM	INACTIVE INGREDIENT	D3741U8K7L	SINEMET CR (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	SINEMET CR (CARBIDOPA AND LEVODOPA) TABLET, EXTENDED RELEASE [MERCK SHARP & DOHME CORP.]	5

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SINEMET ® CR (carbidopa levodopa) Sustained-Release Tablets	Merck Sharp & Dohme Corp.	2019-11-20	HUMAN PRESCRIPTION DRUG LABEL	7