Carbidopa and Levodopa

Product NDC: 0904-7501
11-digit product format: 009047501
Labeler code: 0904
Product ID: 0904-7501_f5d5ad01-a099-46cd-95fc-98ebc80ddc96
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and Levodopa
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA073589
Marketing category: ANDA
Marketing start: 2024-07-02
Substance: CARBIDOPA; LEVODOPA
Active strength: 25; 100 mg/1; mg/1
Pharmacologic classes: Amino Acids, Aromatic [CS], Aromatic Amino Acid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A073589-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	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
A073589-001	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	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	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	A073589-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073589-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073589-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073589-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073589-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073589-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073589-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073589-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073589-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073589-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073589-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073589-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073589-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073589-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073589-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073589-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073589-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073589-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073589-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073589-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073589-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073589-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073589-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073589-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073589-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073589-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073589-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073589-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073589-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073589-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073589-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073589-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073589-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073589-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073589-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073589-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073589-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073589-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073589-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073589-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Carbidopa and Levodopa
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CARBIDOPA HYDRATE	25 mg/1
LEVODOPA	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MNX7R8C5VO	Internal UNII lookup
46627O600J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197444	Internal RxNorm lookup
197445	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3f6d393e-ac84-4a3c-a837-199d1ec71fd2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ce6fab2-d006-4589-8ba0-02cee499cc60	Product name	2	20260128
ebf3b793-6fcd-797b-9d2e-c3faf6d29442	Product name	5	20251106
162160fe-5ea6-4f9d-aa38-c4b780c57046	Product name	1	20250515
0e5ae331-9620-4d1f-8061-7c437c7f1c42	Product name	1	20250312
028fdaca-77da-0dfe-e445-7dfc440fc97e	Product name	4	20250224
7d015b89-35e8-b484-e5db-c0c44814f63c	Product name	7	20241218
de702a02-e9c0-4daf-9101-e44f2c0d4e66	Product name	1	20220609
681917df-580c-4199-896d-b739fbb25ed3	Product name	1	20190412
7d015b89-35e8-b484-e5db-c0c44814f63c	Product name	4	20171212
1fa100ae-9ab3-4df0-afe7-33ab01fd4a41	Product name	1	20150313
88839c8d-b65b-4a50-997b-4c74539855ff	Product name	1	20150313

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-7501-61	Carbidopa and Levodopa	100 in 1 CARTON	TABLET	100		2
0904-7501-61	Carbidopa and Levodopa	1 in 1 BLISTER PACK	TABLET	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7501-61	EA - Each	0904-7501	9c0beca3-65fc-47d8-864c-1e51cd073775	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7501	CARBIDOPA AND LEVODOPA TABLET [MAJOR PHARMACEUTICALS]	2	Current NDC, 2 package rows	20250430_3f6d393e-ac84-4a3c-a837-199d1ec71fd2.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	AvPAK	54f30abc-97fa-00f0-e063-6394a90a155d	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073589 application number: ANDA073589
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Major Pharmaceuticals	3f6d393e-ac84-4a3c-a837-199d1ec71fd2	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073589 application number: ANDA073589 ndc (product): 0904-7501
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): 073589 application number: ANDA073589
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): 073589 application number: ANDA073589
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): 073589 application number: ANDA073589

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197444	carbidopa 25 MG / levodopa 100 MG Oral Tablet	PSN	19d853e2-b8bd-490e-b8d2-b38bec68a139	3
197445	carbidopa 25 MG / levodopa 250 MG Oral Tablet	PSN	19d853e2-b8bd-490e-b8d2-b38bec68a139	3
197444	carbidopa 25 MG / levodopa 100 MG Oral Tablet	SCD	19d853e2-b8bd-490e-b8d2-b38bec68a139	3
197445	carbidopa 25 MG / levodopa 250 MG Oral Tablet	SCD	19d853e2-b8bd-490e-b8d2-b38bec68a139	3
197444	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral Tablet	SY	19d853e2-b8bd-490e-b8d2-b38bec68a139	3
197445	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral Tablet	SY	19d853e2-b8bd-490e-b8d2-b38bec68a139	3
197444	Carbidopa 25 MG / L-DOPA 100 MG Oral Tablet	SY	19d853e2-b8bd-490e-b8d2-b38bec68a139	3
197445	Carbidopa 25 MG / L-DOPA 250 MG Oral Tablet	SY	19d853e2-b8bd-490e-b8d2-b38bec68a139	3
197444	carbidopa 25 MG / levodopa 100 MG Oral Tablet	PSN	3f6d393e-ac84-4a3c-a837-199d1ec71fd2	2
197445	carbidopa 25 MG / levodopa 250 MG Oral Tablet	PSN	3f6d393e-ac84-4a3c-a837-199d1ec71fd2	2
197444	carbidopa 25 MG / levodopa 100 MG Oral Tablet	SCD	3f6d393e-ac84-4a3c-a837-199d1ec71fd2	2
197445	carbidopa 25 MG / levodopa 250 MG Oral Tablet	SCD	3f6d393e-ac84-4a3c-a837-199d1ec71fd2	2
197444	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Oral Tablet	SY	3f6d393e-ac84-4a3c-a837-199d1ec71fd2	2
197445	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral Tablet	SY	3f6d393e-ac84-4a3c-a837-199d1ec71fd2	2
197444	Carbidopa 25 MG / L-DOPA 100 MG Oral Tablet	SY	3f6d393e-ac84-4a3c-a837-199d1ec71fd2	2
197445	Carbidopa 25 MG / L-DOPA 250 MG Oral Tablet	SY	3f6d393e-ac84-4a3c-a837-199d1ec71fd2	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7501-61	00904750161	100 BLISTER PACK in 1 CARTON (0904-7501-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2024-07-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARBIDOPA AND LEVODOPA TABLETS, USP	Major Pharmaceuticals	2026-05-28	HUMAN PRESCRIPTION DRUG LABEL	3
CARBIDOPA AND LEVODOPA TABLETS, USP	Cardinal Health 107, LLC	2026-04-16	HUMAN PRESCRIPTION DRUG LABEL	3