Carbidopa and Levodopa

Product NDC: 50268-202
Requested package NDC: 50268-202-15
11-digit product format: 502680202
Labeler code: 50268
Product ID: 50268-202_54f30b53-6bd0-225e-e063-6294a90af421
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and Levodopa
Dosage form: TABLET
Route: ORAL
Labeler: AvPAK
Application: ANDA073589
Marketing category: ANDA
Marketing start: 2026-06-23
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 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
2026-09-14 22:38:34	2026-08	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073589-001	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	1992-08-28	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A073589-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073589-001	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197444	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
54f30abc-97fa-00f0-e063-6394a90a155d	Available on FDA.report

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 ndc (package): 50268-202-15 ndc (product): 50268-202 ndc11 (package): 50268020215
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50268-202-15	50268020215	50 BLISTER PACK in 1 BOX (50268-202-15) / 1 TABLET in 1 BLISTER PACK (50268-202-11)	50 blister pack	2026-06-23	No	No	Current