Carbidopa and levodopa

Product NDC: 42291-488
11-digit product format: 422910488
Labeler code: 42291
Product ID: 42291-488_485f790b-2d36-cffd-e063-6294a90a1cb7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and levodopa
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA074260
Marketing category: ANDA
Marketing start: 2024-02-21
Substance: CARBIDOPA; LEVODOPA
Active strength: 25; 250 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 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…`

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	250 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
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
11e706c4-433c-1ea6-e063-6294a90ad360	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
42291-488-01	Carbidopa and levodopa	100 in 1 BOTTLE	TABLET	100		2
42291-488-10	Carbidopa and levodopa	1000 in 1 BOTTLE	TABLET	1000		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-488-01	EA - Each	42291-488	cf8ce329-5159-41fb-9c81-f170cf86bc6d	1	2024-03-12
42291-488-10	EA - Each	42291-488	eeea970f-e08a-4bd2-ab9a-3ad65f20590b	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-488	CARBIDOPA AND LEVODOPA TABLET [AVKARE]	1	Current NDC, 2 package rows	20240223_11e706c4-433c-1ea6-e063-6294a90ad360.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 ndc (product): 42291-488
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197445	carbidopa 25 MG / levodopa 250 MG Oral Tablet	PSN	11e706c4-433c-1ea6-e063-6294a90ad360	2
197445	carbidopa 25 MG / levodopa 250 MG Oral Tablet	SCD	11e706c4-433c-1ea6-e063-6294a90ad360	2
197445	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 250 MG Oral Tablet	SY	11e706c4-433c-1ea6-e063-6294a90ad360	2
197445	Carbidopa 25 MG / L-DOPA 250 MG Oral Tablet	SY	11e706c4-433c-1ea6-e063-6294a90ad360	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42291-488-01	42291048801	100 TABLET in 1 BOTTLE (42291-488-01)	100 tablet	2024-02-21	No	No	Current
42291-488-10	42291048810	1000 TABLET in 1 BOTTLE (42291-488-10)	1000 tablet	2024-02-21	No	No	Current