Carbidopa and Levodopa

Product NDC: 0615-8011
11-digit product format: 006158011
Labeler code: 0615
Product ID: 0615-8011_9cf5c2a0-7641-4fc7-952d-3e003cc8519f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and Levodopa
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA073607
Marketing category: ANDA
Marketing start: 1993-01-01
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	0615-8011		D	Discontinued by firm		2026-08-03
excluded package	package	0615-8011	0615-8011-39	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 · 30 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	0615-8011-39	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	0615-8011-39	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	0615-8011-39	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	0615-8011-39	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	0615-8011-39	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	0615-8011-39	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	0615-8011-39	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	0615-8011-39	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	0615-8011-39	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	0615-8011-39	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	0615-8011-39	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	0615-8011-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
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	0615-8011-39	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	0615-8011-39	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	0615-8011-39	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A073607-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB		1992-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073607-001	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 2 · 41 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	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A073607-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073607-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073607-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073607-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073607-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073607-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073607-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073607-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073607-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073607-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073607-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073607-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073607-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073607-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073607-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073607-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073607-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073607-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073607-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073607-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073607-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073607-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073607-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073607-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073607-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073607-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073607-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073607-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073607-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073607-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073607-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073607-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073607-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073607-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073607-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073607-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073607-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073607-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073607-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073607-001	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-8011-39	2021-04-09	C162847	48780-1	9d75b9cf-e972-f424-e053-dadaa90a57ce	CARBIDOPA AND LEVODOPA TABLETS USP Rx only
0615-8011-39	2020-01-31	C162847	48780-1	9d75b9cf-e972-f424-e053-dadaa90a57ce	CARBIDOPA AND LEVODOPA TABLETS USP Rx only

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Major Pharmaceuticals	3f6d393e-ac84-4a3c-a837-199d1ec71fd2	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073607 application number: ANDA073607
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Dr. Reddy's Laboratories Inc	87ab55c9-203d-d595-3e3e-0e38f2f6d9c4	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073607 application number: ANDA073607
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Cardinal Health 107, LLC	19d853e2-b8bd-490e-b8d2-b38bec68a139	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073607 application number: ANDA073607
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	NCS HealthCare of KY, LLC dba Vangard Labs	45909de3-0852-4e61-8a9e-23f8fcc2463a	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073607 application number: ANDA073607

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 TABLETS USP Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2016-05-20	HUMAN PRESCRIPTION DRUG LABEL	2