Carbidopa and Levodopa

Product NDC: 0615-8275
Requested package NDC: 0615-8275-39
11-digit product format: 006158275
Labeler code: 0615
Product ID: 0615-8275_bc1cbf1d-80c9-4c44-aa46-9847834c3b4d
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: 2018-07-16
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: 2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0615-8275	0615-8275-39	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-8275	0615-8275-39	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-8275	0615-8275-39	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8275	CARBIDOPA AND LEVODOPA TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	10	Legacy NDC	20240802_19d3f2c4-4b7b-4d67-8047-4fb3b4dd7efd.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 · 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0615-8275-39	00615827539	30 TABLET in 1 BLISTER PACK (0615-8275-39)	30 tablet	2019-03-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbidopa- Levodopa Tabs 8251 8275	NCS HealthCare of KY, LLC dba Vangard Labs	2024-04-11	HUMAN PRESCRIPTION DRUG LABEL	10