Carbidopa and Levodopa

Product NDC: 0378-5053
11-digit product format: 003785053
Labeler code: 0378
Product ID: 0378-5053_c9f6ebac-312d-4f8f-b19c-c9f12e97588f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbidopa and levodopa
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA078893
Marketing category: ANDA
Marketing start: 2008-09-18
Marketing end: 0000-00-00
Substance: CARBIDOPA; LEVODOPA
Active strength: 25 mg/1; mg/1
Pharmacologic classes: Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0378-5053		D	Discontinued by firm		2026-08-07
excluded package	package	0378-5053	0378-5053-01	D	Discontinued by firm		2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0378-5053-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0378-5053-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0378-5053-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0378-5053-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0378-5053-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0378-5053-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0378-5053-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0378-5053-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0378-5053-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0378-5053-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0378-5053-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-5053-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A078893-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18
A078893-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18
A078893-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078893-001	AB
A078893-002	AB
A078893-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2008-09-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078893-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078893-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078893-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET, ORALLY DISINTEGRATING / ORAL		2008-09-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078893-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078893-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078893-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078893-003	AB	1	`31067a03dcf5…`
2019-12-13 00:20 UTC	2019-12	A078893-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078893-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078893-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078893-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078893-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078893-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078893-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078893-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078893-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078893-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078893-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078893-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078893-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078893-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078893-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078893-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078893-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078893-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078893-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078893-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078893-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078893-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078893-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078893-003	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078893-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078893-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A078893-003	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-5053-01	EA - Each	0378-5053	48aa30aa-740f-4340-9f1b-c84f6fb5526e	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, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4
LEVODOPA	ACTIVE INGREDIENT	46627O600J	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4
CARBIDOPA ANHYDROUS	ACTIVE MOIETY	KR87B45RGH	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4
LEVODOPA	ACTIVE MOIETY	46627O600J	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4
ASPARTAME	INACTIVE INGREDIENT	Z0H242BBR1	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	CARBIDOPA AND LEVODOPA TABLET, ORALLY DISINTEGRATING [MYLAN PHARMACEUTICALS INC.]	4

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Rising Pharma Holdings, Inc.	302bfe03-d222-4a87-80ff-f2dbfb9a07f4	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078893 application number: ANDA078893

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	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-5053-01	00378505301	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5053-01)	2008-09-18	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.	2016-09-14	HUMAN PRESCRIPTION DRUG LABEL	6