Entacapone

Product NDC: 0527-1830
11-digit product format: 005271830
Labeler code: 0527
Product ID: 0527-1830_071b5720-d208-9e0e-e063-6294a90a0513
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: entacapone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA206669
Marketing category: ANDA
Marketing start: 2018-12-20
Substance: ENTACAPONE
Active strength: 200 mg/1
Pharmacologic classes: Catechol O-Methyltransferase Inhibitors [MoA], Catechol-O-Methyltransferase Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0527-1830	0527-1830-35	D	Discontinued by firm		2026-08-17

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 42.

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
A206669-001	ENTACAPONE	ENTACAPONE	200MG	TABLET / ORAL	AB		2018-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206669-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206669-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2018-10-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206669-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206669-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206669-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206669-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206669-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206669-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206669-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206669-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206669-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206669-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206669-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206669-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206669-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206669-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206669-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206669-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206669-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206669-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206669-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206669-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206669-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206669-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206669-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206669-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206669-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206669-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206669-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206669-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206669-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206669-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206669-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206669-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206669-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206669-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206669-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206669-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206669-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206669-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206669-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206669-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Entacapone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ENTACAPONE	200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4975G9NM6T	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
317094	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0bf133e4-1c17-4358-9a43-144e6bf2564f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5ce6fab2-d006-4589-8ba0-02cee499cc60	Product name	2	20260128
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
6a098371-84f5-7ced-0ac5-ed90d535b476	Product name	6	20220927
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0527-1830-35	Entacapone	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60		5
0527-1830-37	Entacapone	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-1830-37	EA - Each	0527-1830	627467b7-fb53-4982-8ed0-578ce38d2674	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-1830	ENTACAPONE TABLET, FILM COATED [LANNETT COMPANY, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20231007_0bf133e4-1c17-4358-9a43-144e6bf2564f.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
Entacapone	ENTACAPONE	Rising Pharma Holdings, Inc.	ee02a04a-4b42-4cfa-8d9d-b1459c0ee9fd	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206669 application number: ANDA206669
Entacapone	ENTACAPONE	Lannett Company, Inc.	0bf133e4-1c17-4358-9a43-144e6bf2564f	2023-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206669 application number: ANDA206669 ndc (product): 0527-1830

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4975G9NM6T	ENTACAPONE	130929-57-6	ENTACAPONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
317094	entacapone 200 MG Oral Tablet	PSN	0bf133e4-1c17-4358-9a43-144e6bf2564f	5
317094	entacapone 200 MG Oral Tablet	SCD	0bf133e4-1c17-4358-9a43-144e6bf2564f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-1830-35	00527183035	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1830-35)	2018-12-20	0000-00-00	No	No	Current
0527-1830-37	00527183037	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1830-37)	2018-12-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Entacapone Tablets USP, 200 mg	Lannett Company, Inc. \| Sunshine Lake Pharma Co., Ltd.	2023-10-07	HUMAN PRESCRIPTION DRUG LABEL	5