Carbidopa and Levodopa

Product NDC: 51862-855
Requested package NDC: 51862-855-01
11-digit product format: 518620855
Labeler code: 51862
Product ID: 51862-855_b2a61d0f-e190-494b-8016-f0d824d9b3dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Carbidopa and Levodopa
Dosage form: TABLET
Route: ORAL
Labeler: Mayne Pharma Inc.
Application: ANDA073618
Marketing category: ANDA
Marketing start: 2018-07-16
Marketing end: 0000-00-00
Substance: CARBIDOPA; LEVODOPA
Active strength: 10 mg/1; mg/1
Pharmacologic classes: Aromatic Amino Acid [EPC],Amino Acids, Aromatic [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	51862-855	51862-855-01	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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-855	51862-855-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-855	51862-855-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A073618-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	10MG;100MG	TABLET / ORAL	AB		1992-08-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073618-001	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 2 · 41 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	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073618-001	CARBIDOPA AND LEVODOPA	10MG;100MG	TABLET / ORAL	AB	1992-08-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A073618-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073618-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073618-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073618-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073618-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073618-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073618-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073618-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073618-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073618-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073618-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073618-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073618-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073618-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073618-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073618-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073618-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073618-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073618-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073618-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073618-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073618-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073618-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073618-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073618-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073618-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073618-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073618-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073618-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073618-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073618-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073618-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073618-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073618-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073618-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073618-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073618-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073618-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073618-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073618-001	AB	1	`cb3db0bc1861…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-855-01	EA - Each	51862-855	b5d02149-c073-4729-ae96-5a66efd69140	1	2019-03-12
51862-855-05	EA - Each	51862-855	8a80c6a0-dce4-412d-9eb8-e45d03dcefcc	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51862-855	CARBIDOPA AND LEVODOPA TABLET [MAYNE PHARMA COMMERCIAL LLC]	7	Legacy NDC	20250402_d92bf9c8-ec59-4a7d-996f-2727d6e6adc5.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Dr. Reddy's Laboratories Inc	87ab55c9-203d-d595-3e3e-0e38f2f6d9c4	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073618 application number: ANDA073618
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	NCS HealthCare of KY, LLC dba Vangard Labs	45909de3-0852-4e61-8a9e-23f8fcc2463a	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073618 application number: ANDA073618

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
197443	carbidopa 10 MG / levodopa 100 MG Oral Tablet	PSN	180c0ec8-6314-4681-8b69-a5d612c5c927	10
197443	carbidopa 10 MG / levodopa 100 MG Oral Tablet	SCD	180c0ec8-6314-4681-8b69-a5d612c5c927	10
197443	carbidopa (as carbidopa monohydrate) 10 MG / levodopa 100 MG Oral Tablet	SY	180c0ec8-6314-4681-8b69-a5d612c5c927	10
197443	Carbidopa 10 MG / L-DOPA 100 MG Oral Tablet	SY	180c0ec8-6314-4681-8b69-a5d612c5c927	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-855-01	51862085501	100 TABLET in 1 BOTTLE (51862-855-01)	100 tablet	2018-07-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CARBIDOPA AND LEVODOPA TABLETS, USP	Mayne Pharma Commercial LLC \| Mayne Pharma International Pty Ltd \| Catalent Greenville, Inc.	2025-03-31	HUMAN PRESCRIPTION DRUG LABEL	7
CARBIDOPA AND LEVODOPA TABLETS, USP	Golden State Medical Supply \| Golden State Medical Supply, Inc.	2022-08-11	HUMAN PRESCRIPTION DRUG LABEL	6
CARBIDOPA AND LEVODOPA TABLETS, USP	McKesson Corporation dba RX Pak	2021-02-03	HUMAN PRESCRIPTION DRUG LABEL	8
CARBIDOPA AND LEVODOPA TABLETS, USP	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2021-01-20	HUMAN PRESCRIPTION DRUG LABEL	10