Carbidopa and Levodopa

Product NDC: 70518-3250
Requested package NDC: 70518-3250-0
11-digit product format: 705183250
Labeler code: 70518
Product ID: 70518-3250_cf563392-4524-03e7-e053-2995a90adaeb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and Levodopa
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA214092
Marketing category: ANDA
Marketing start: 2021-10-20
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3250	70518-3250-0	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A214092-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07
A214092-002	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07
A214092-003	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214092-001	AB
A214092-002	AB
A214092-003	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 3 · 99 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	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214092-002	CARBIDOPA AND LEVODOPA	25MG;100MG	TABLET / ORAL	AB	2021-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214092-003	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	2021-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214092-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	2021-05-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 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	A214092-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214092-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214092-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214092-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214092-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214092-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214092-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214092-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214092-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214092-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214092-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214092-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214092-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214092-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214092-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214092-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214092-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214092-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214092-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214092-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214092-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214092-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214092-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214092-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214092-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214092-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214092-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214092-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214092-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214092-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214092-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214092-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214092-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214092-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214092-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214092-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214092-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214092-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214092-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214092-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-3250-0	2023-03-23	C162847	48780-1	f386c649-cb34-0266-e053-dadaa90a7c1a	Carbidopa and Levodopa Tablets, USP Rx only
70518-3250-0	2023-01-30	C162847	48780-1	f386c649-cb34-0266-e053-dadaa90a7c1a	Carbidopa and Levodopa Tablets, USP Rx only

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Westminster Pharmaceuticals, LLC	3f026272-32a6-4c98-8b6f-d910c7f58aa2	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	ScieGen Pharmaceuticals Inc	a32afa84-7bc0-4bd3-bc50-55d738f3d7ce	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Coupler LLC	2d9469ba-02b2-0cfc-e063-6394a90a6292	2025-02-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	f207467e-ac62-446a-b42e-371efd0c7b2b	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	7219022c-a56a-4501-9437-601f6cb34e6b	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	84831a49-02d8-421e-8f05-f1358d7149cb	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	A-S Medication Solutions	08f51366-0a54-48f5-8f10-940745850325	2023-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Aphena Pharma Solutions - Tennessee, LLC	289ca0b7-1b4f-4653-b329-066447d18c13	2022-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Proficient Rx LP	0215da3f-13a0-400d-ac2d-20c839bd89ef	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214092 application number: ANDA214092

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
70518-3250-0	70518325000	30 TABLET in 1 BLISTER PACK (70518-3250-0)	30 tablet	2021-10-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbidopa and Levodopa Tablets, USP Rx only	REMEDYREPACK INC.	2023-03-23	HUMAN PRESCRIPTION DRUG LABEL	2