Carbidopa and Levodopa

Product NDC: 43353-327
11-digit product format: 433530327
Labeler code: 43353
Product ID: 43353-327_362dfbf2-fc33-4fa7-a407-192aab05c3d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carbidopa and levodopa
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA075091
Marketing category: ANDA
Marketing start: 2000-04-26
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	43353-327		I	Inactivated by FDA		2026-08-03
excluded package	package	43353-327	43353-327-09	I	Inactivated by FDA		2026-08-03

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 · 30 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	43353-327-09	`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	43353-327-09	`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	43353-327-09	`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	43353-327-09	`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	43353-327-09	`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	43353-327-09	`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	43353-327-09	`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	43353-327-09	`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	43353-327-09	`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	43353-327-09	`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	43353-327-09	`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	43353-327-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-327-09	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-327-09	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-327-09	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-327-09	2023-01-30	C162847	48780-1	f386c649-ec8e-0266-e053-dadaa90a7c1a	8dda2a01-637b-4bf6-9c5d-00a77870be02

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43353-327-09	Carbidopa and Levodopa	9000 in 1 BOTTLE, PLASTIC	TABLET, EXTENDED RELEASE	9000		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-327-09	EA - Each	43353-327	4900c922-bb75-42fb-980d-fbcd35b98150	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-327	CARBIDOPA AND LEVODOPA TABLET, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC, 1 package rows	20191221_8dda2a01-637b-4bf6-9c5d-00a77870be02.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
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	8dda2a01-637b-4bf6-9c5d-00a77870be02	2
308988	carbidopa 25 MG / levodopa 100 MG Extended Release Oral Tablet	SCD	8dda2a01-637b-4bf6-9c5d-00a77870be02	2
308988	carbidopa (as carbidopa monohydrate) 25 MG / levodopa 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	8dda2a01-637b-4bf6-9c5d-00a77870be02	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-327-09	43353032709	9000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (43353-327-09)	2017-05-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Carbidopa and Levodopa - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2019-12-18	HUMAN PRESCRIPTION DRUG LABEL	2