Carbidopa and Levodopa

Product NDC: 0904-6238
11-digit product format: 009046238
Labeler code: 0904
Product ID: 0904-6238_dde744df-ff6f-4123-b94e-3549e1e27865
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and Levodopa
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA074260
Marketing category: ANDA
Marketing start: 2011-02-11
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	0904-6238		D	Discontinued by firm		2026-08-07
excluded package	package	0904-6238	0904-6238-61	D	Discontinued by firm		2026-08-07

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 · 4 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	0904-6238-61	`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	0904-6238-61	`f5e01cc5f278…`	`a2eaf40c39c3…`

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

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	Approval date
A074260-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03
A074260-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03
A074260-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074260-001	AB
A074260-002	AB
A074260-003	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 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074260-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB		1993-09-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074260-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	RS	1993-09-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074260-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1993-09-03	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A074260-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074260-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074260-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074260-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074260-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074260-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074260-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074260-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074260-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074260-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074260-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074260-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074260-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074260-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074260-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074260-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074260-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074260-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074260-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074260-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074260-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074260-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074260-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074260-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074260-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074260-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074260-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074260-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074260-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074260-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074260-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074260-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074260-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074260-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074260-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074260-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074260-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074260-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074260-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074260-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6238-61	EA - Each	0904-6238	a7a5ccd3-d841-4444-959a-4848b14060a3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CARBIDOPA	ACTIVE INGREDIENT	MNX7R8C5VO	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	3
LEVODOPA	ACTIVE INGREDIENT	46627O600J	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	3
CARBIDOPA	ACTIVE MOIETY	MNX7R8C5VO	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	3
LEVODOPA	ACTIVE MOIETY	46627O600J	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	3
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6238	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	15	Legacy NDC	20240627_2b9d6e2d-40e0-433c-a8f4-c1a61ccc2015.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	Teva Pharmaceuticals USA, Inc.	4ace5274-b6cf-414c-b9c0-f60e28a9cea5	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	AvKARE	e232e055-7892-3541-e053-2995a90a1e74	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	AvKARE	da471cd4-dcee-b026-e053-2a95a90a3d81	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	AvKARE	11e706c4-433c-1ea6-e063-6294a90ad360	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	American Health Packaging	a62ae74d-6677-459c-b338-00e6851a1e00	2025-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	6d8968a1-0317-464a-bd03-4f683f562de2	2023-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260
Carbidopa and levodopa	CARBIDOPA AND LEVODOPA	Aphena Pharma Solutions - Tennessee, LLC	64254508-dbe7-4512-902d-f4a6ef2bfdf8	2022-10-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074260 application number: ANDA074260

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
0904-6238-61	00904623861	100 BLISTER PACK in 1 CARTON (0904-6238-61) > 1 TABLET in 1 BLISTER PACK	100 blister pack	2011-02-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbidopa and Levodopa Tablets, USP	Major Pharmaceuticals	2024-06-25	HUMAN PRESCRIPTION DRUG LABEL	15