Carbidopa and Levodopa

Product NDC: 0615-4569
11-digit product format: 006154569
Labeler code: 0615
Product ID: 0615-4569_5b049995-c25b-40e5-8750-739125ad1b51
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and Levodopa
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA075091
Marketing category: ANDA
Marketing start: 2011-10-18
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: E
Listing certified through: 2017-12-31
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	0615-4569		D	Discontinued by firm		2026-08-03
excluded package	package	0615-4569	0615-4569-39	D	Discontinued by firm		2026-08-03

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-4569-39	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-4569-39	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-4569-39	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-4569-39	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-4569-39	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-4569-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-4569-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-4569-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-4569-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-4569-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-4569-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-4569-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0615-4569-39	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0615-4569-39	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0615-4569-39	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0615-4569-39	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-4569-39	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-4569-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-4569-39	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A075091-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB		1999-09-30
A075091-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075091-001	AB
A075091-002	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 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075091-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075091-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075091-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075091-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075091-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075091-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075091-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075091-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075091-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075091-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075091-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075091-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075091-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075091-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075091-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075091-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075091-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075091-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075091-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075091-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075091-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075091-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075091-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075091-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075091-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075091-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075091-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075091-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075091-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075091-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075091-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075091-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075091-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075091-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075091-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075091-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075091-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075091-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075091-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075091-002	AB	1	`782e0a99824c…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-4569-39	2022-11-02	C162847	48780-1	9d75b9d1-2943-f424-e053-dadaa90a57ce	CARBIDOPA AND LEVODOPA EXTENDED -RELEASE TABLETS, USP 25 mg /100 mg and 50 mg/200 mg Rx only
0615-4569-39	2020-01-31	C162847	48780-1	9d75b9d1-2943-f424-e053-dadaa90a57ce	CARBIDOPA AND LEVODOPA EXTENDED -RELEASE TABLETS, USP 25 mg /100 mg and 50 mg/200 mg Rx only

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBIDOPA	ACTIVE INGREDIENT	MNX7R8C5VO	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
LEVODOPA	ACTIVE INGREDIENT	46627O600J	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
CARBIDOPA ANHYDROUS	ACTIVE MOIETY	KR87B45RGH	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
LEVODOPA	ACTIVE MOIETY	46627O600J	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Mylan Pharmaceuticals Inc.	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075091 application number: ANDA075091
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Safecor Health, LLC	015bc056-ee86-4006-ae7c-689b95e566f4	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075091 application number: ANDA075091
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Mylan Institutional Inc.	16f9e4d1-6953-4d4f-b4cf-ad95a856ac25	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075091 application number: ANDA075091

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
CARBIDOPA AND LEVODOPA EXTENDED -RELEASE TABLETS, USP 25 mg /100 mg and 50 mg/200 mg Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2015-11-02	HUMAN PRESCRIPTION DRUG LABEL	14