Carbidopa and Levodopa

Product NDC: 0378-0088
11-digit product format: 003780088
Labeler code: 0378
Product ID: 0378-0088_164375a9-db50-4cb3-86ca-a52a3e74cc83
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbidopa and levodopa
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA075091
Marketing category: ANDA
Marketing start: 2000-04-26
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075091-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB		1999-09-30
A075091-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB		2000-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075091-001	AB
A075091-002	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 3 · 82 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	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075091-001	CARBIDOPA AND LEVODOPA	50MG;200MG	TABLET, EXTENDED RELEASE / ORAL	AB	1999-09-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075091-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, EXTENDED RELEASE / ORAL	AB	2000-04-21	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A075091-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075091-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075091-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075091-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075091-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075091-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075091-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075091-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075091-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075091-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075091-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075091-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075091-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075091-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075091-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075091-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075091-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075091-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075091-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075091-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075091-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075091-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075091-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075091-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075091-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075091-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075091-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075091-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075091-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075091-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075091-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075091-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075091-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075091-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075091-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075091-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075091-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075091-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075091-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075091-002	AB	1	`782e0a99824c…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308988	Internal RxNorm lookup
308989	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
aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	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
0378-0088-01	Carbidopa and Levodopa	100 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	100		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0088-01	EA - Each	0378-0088	29ecee5f-af93-4575-ad1f-d5fb0775e528	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, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
LEVODOPA	ACTIVE INGREDIENT	46627O600J	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
CARBIDOPA ANHYDROUS	ACTIVE MOIETY	KR87B45RGH	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
LEVODOPA	ACTIVE MOIETY	46627O600J	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	14
CARBIDOPA	ACTIVE INGREDIENT	MNX7R8C5VO	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
LEVODOPA	ACTIVE INGREDIENT	46627O600J	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
CARBIDOPA ANHYDROUS	ACTIVE MOIETY	KR87B45RGH	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
LEVODOPA	ACTIVE MOIETY	46627O600J	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	7
CARBIDOPA	ACTIVE INGREDIENT	MNX7R8C5VO	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	4
LEVODOPA	ACTIVE INGREDIENT	46627O600J	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	4
CARBIDOPA ANHYDROUS	ACTIVE MOIETY	KR87B45RGH	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	4
LEVODOPA	ACTIVE MOIETY	46627O600J	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-0088	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	13	Current NDC, Legacy NDC, 1 package rows	20221229_aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Mylan Pharmaceuticals Inc.	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075091 application number: ANDA075091 ndc (product): 0378-0088
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Safecor Health, LLC	015bc056-ee86-4006-ae7c-689b95e566f4	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075091 application number: ANDA075091
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Mylan Institutional Inc.	16f9e4d1-6953-4d4f-b4cf-ad95a856ac25	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075091 application number: ANDA075091

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
308988	carbidopa 25 MG / levodopa 100 MG Extended Release Oral Tablet	PSN	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	15
308989	carbidopa 50 MG / levodopa 200 MG Extended Release Oral Tablet	PSN	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	15
308988	carbidopa 25 MG / levodopa 100 MG Extended Release Oral Tablet	SCD	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	15
308989	carbidopa 50 MG / levodopa 200 MG Extended Release Oral Tablet	SCD	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	15
308988	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral Tablet	SY	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	15
308989	carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral Tablet	SY	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	15
308988	Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral Tablet	SY	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	15
308989	Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral Tablet	SY	aa5028d6-fd0a-4cf1-b708-c93bb2a7c76a	15
308988	carbidopa 25 MG / levodopa 100 MG Extended Release Oral Tablet	PSN	16f9e4d1-6953-4d4f-b4cf-ad95a856ac25	13
308989	carbidopa 50 MG / levodopa 200 MG Extended Release Oral Tablet	PSN	16f9e4d1-6953-4d4f-b4cf-ad95a856ac25	13
308988	carbidopa 25 MG / levodopa 100 MG Extended Release Oral Tablet	SCD	16f9e4d1-6953-4d4f-b4cf-ad95a856ac25	13
308989	carbidopa 50 MG / levodopa 200 MG Extended Release Oral Tablet	SCD	16f9e4d1-6953-4d4f-b4cf-ad95a856ac25	13
308988	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral Tablet	SY	16f9e4d1-6953-4d4f-b4cf-ad95a856ac25	13
308989	carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral Tablet	SY	16f9e4d1-6953-4d4f-b4cf-ad95a856ac25	13
308988	Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral Tablet	SY	16f9e4d1-6953-4d4f-b4cf-ad95a856ac25	13
308989	Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral Tablet	SY	16f9e4d1-6953-4d4f-b4cf-ad95a856ac25	13
308988	carbidopa 25 MG / levodopa 100 MG Extended Release Oral Tablet	PSN	8dda2a01-637b-4bf6-9c5d-00a77870be02	2
308988	carbidopa 25 MG / levodopa 100 MG Extended Release Oral Tablet	PSN	015bc056-ee86-4006-ae7c-689b95e566f4	2
308989	carbidopa 50 MG / levodopa 200 MG Extended Release Oral Tablet	PSN	015bc056-ee86-4006-ae7c-689b95e566f4	2
308988	carbidopa 25 MG / levodopa 100 MG Extended Release Oral Tablet	SCD	8dda2a01-637b-4bf6-9c5d-00a77870be02	2
308988	carbidopa 25 MG / levodopa 100 MG Extended Release Oral Tablet	SCD	015bc056-ee86-4006-ae7c-689b95e566f4	2
308989	carbidopa 50 MG / levodopa 200 MG Extended Release Oral Tablet	SCD	015bc056-ee86-4006-ae7c-689b95e566f4	2
308988	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral Tablet	SY	8dda2a01-637b-4bf6-9c5d-00a77870be02	2
308988	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 100 MG Extended Release Oral Tablet	SY	015bc056-ee86-4006-ae7c-689b95e566f4	2
308989	carbidopa (as carbidopa monohydrate) 50 MG / levodopa 200 MG Extended Release Oral Tablet	SY	015bc056-ee86-4006-ae7c-689b95e566f4	2
308988	Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral Tablet	SY	8dda2a01-637b-4bf6-9c5d-00a77870be02	2
308988	Carbidopa 25 MG / L-DOPA 100 MG Extended Release Oral Tablet	SY	015bc056-ee86-4006-ae7c-689b95e566f4	2
308989	Carbidopa 50 MG / L-DOPA 200 MG Extended Release Oral Tablet	SY	015bc056-ee86-4006-ae7c-689b95e566f4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0088-01	00378008801	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0088-01)	2000-04-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbidopa and Levodopa - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2026-04-24	HUMAN PRESCRIPTION DRUG LABEL	15
Carbidopa and Levodopa - Safecor Health, LLC	Safecor Health, LLC	2026-03-19	HUMAN PRESCRIPTION DRUG LABEL	2
Carbidopa and Levodopa - Mylan Institutional Inc.	Mylan Institutional Inc.	2025-07-18	HUMAN PRESCRIPTION DRUG LABEL	13
Carbidopa and Levodopa - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2019-12-18	HUMAN PRESCRIPTION DRUG LABEL	2
CARBIDOPA AND LEVODOPA EXTENDED -RELEASE TABLETS, USP 25 mg /100 mg and 50 mg/200 mg Rx only	NCS HealthCare of KY, Inc dba Vangard Labs	2015-11-02	HUMAN PRESCRIPTION DRUG LABEL	14