Carbidopa and Levodopa

Product NDC: 0378-0085
11-digit product format: 003780085
Labeler code: 0378
Product ID: 0378-0085_26fe1be4-3d62-438c-a3d3-21999097cbae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbidopa and levodopa
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA090324
Marketing category: ANDA
Marketing start: 2011-05-16
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	0378-0085		D	Discontinued by firm		2026-10-16
excluded package	package	0378-0085	0378-0085-01	D	Discontinued by firm		2026-10-16

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A090324-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL		2009-09-28
A090324-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28
A090324-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL		2009-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090324-002	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 4 · 132 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
2026-10-15 13:18:30	2026-09	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL		2009-09-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL		2009-09-28	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL		2009-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL		2009-09-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL		2009-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL		2009-09-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL		2009-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL		2009-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL		2009-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL		2009-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL		2009-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL		2009-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2009-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2009-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2009-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2009-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2009-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2009-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2009-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2009-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2009-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2009-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2009-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2009-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2009-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090324-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2009-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090324-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2009-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090324-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2009-09-28	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 3 of 3 · 118 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090324-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090324-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090324-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090324-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090324-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090324-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090324-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090324-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090324-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090324-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090324-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090324-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090324-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090324-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090324-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090324-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090324-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090324-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090324-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090324-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090324-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090324-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090324-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090324-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090324-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090324-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090324-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090324-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090324-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090324-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A090324-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090324-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090324-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A090324-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090324-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090324-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090324-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090324-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0085-01	EA - Each	0378-0085	123a9f30-a9ec-45ff-86d9-5eda54afa944	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 [MYLAN PHARMACEUTICALS INC.]	5
LEVODOPA	ACTIVE INGREDIENT	46627O600J	CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]	5
CARBIDOPA ANHYDROUS	ACTIVE MOIETY	KR87B45RGH	CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]	5
LEVODOPA	ACTIVE MOIETY	46627O600J	CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]	5
CARBIDOPA	ACTIVE INGREDIENT	MNX7R8C5VO	CARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]	4
LEVODOPA	ACTIVE INGREDIENT	46627O600J	CARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]	4
CARBIDOPA ANHYDROUS	ACTIVE MOIETY	KR87B45RGH	CARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]	4
LEVODOPA	ACTIVE MOIETY	46627O600J	CARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CARBIDOPA AND LEVODOPA TABLET [MYLAN INSTITUTIONAL INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-0085	CARBIDOPA AND LEVODOPA TABLET [MYLAN PHARMACEUTICALS INC.]	11	Legacy NDC	20250101_3c768639-8a70-4d12-ad93-827bb42ec6b7.zip

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
0378-0085-01	00378008501	100 TABLET in 1 BOTTLE, PLASTIC (0378-0085-01)	100 tablet	2011-05-16	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.	2022-10-07	HUMAN PRESCRIPTION DRUG LABEL	11
Carbidopa and Levodopa Tablets	Golden State Medical Supply	2021-02-04	HUMAN PRESCRIPTION DRUG LABEL	5
Carbidopa and Levodopa - Mylan Institutional Inc.	Mylan Institutional Inc.	2019-10-28	HUMAN PRESCRIPTION DRUG LABEL	7