Entacapone

Product NDC: 0904-6822
11-digit product format: 009046822
Labeler code: 0904
Product ID: 0904-6822_3e89aac1-4b38-41fd-bbd7-af716570f424
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Entacapone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA203437
Marketing category: ANDA
Marketing start: 2015-06-19
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	0904-6822	0904-6822-04	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
A203437-001	ENTACAPONE	ENTACAPONE	200MG	TABLET / ORAL	AB		2015-06-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203437-001	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	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203437-001	ENTACAPONE	200MG	TABLET / ORAL	AB	2015-06-19	`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	A203437-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203437-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203437-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203437-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203437-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203437-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203437-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203437-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203437-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203437-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203437-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203437-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203437-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203437-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203437-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203437-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203437-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203437-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203437-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203437-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203437-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203437-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203437-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203437-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203437-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203437-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203437-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203437-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203437-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203437-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203437-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203437-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203437-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203437-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203437-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203437-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203437-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203437-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203437-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203437-001	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
863025af-2b71-477d-baa9-3ce7f435e385	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
6a098371-84f5-7ced-0ac5-ed90d535b476	Product name	6	20220927

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-6822-04	Entacapone	30 in 1 CARTON	TABLET, FILM COATED	30	6
0904-6822-04	Entacapone	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	6
0904-6822-07	Entacapone	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	6
0904-6822-07	Entacapone	30 in 1 CARTON	TABLET, FILM COATED	30	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6822-04	EA - Each	0904-6822	9dd72b39-ed12-4602-9e9a-9ed64ebf3f24	1	2019-11-12
0904-6822-07	EA - Each	0904-6822	081e6c31-d76f-41bc-a49e-e1c79aa60c82	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6822	ENTACAPONE TABLET, FILM COATED [MAJOR PHARMACEUTICALS]	5	Current NDC, Legacy NDC, 4 package rows	20240503_863025af-2b71-477d-baa9-3ce7f435e385.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Entacapone	ENTACAPONE	AvPAK	1fab63f2-9257-6998-5658-7e98db51b184	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203437 application number: ANDA203437
Entacapone	ENTACAPONE	Major Pharmaceuticals	863025af-2b71-477d-baa9-3ce7f435e385	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203437 application number: ANDA203437 ndc (product): 0904-6822
Entacapone	ENTACAPONE	American Health Packaging	3d4ec829-7835-4d59-bc5b-6ce38811fba7	2024-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203437 application number: ANDA203437
Entacapone	ENTACAPONE	Aurobindo Pharma Limited	d9cc1327-5474-4136-970a-ec40c41975b2	2024-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203437 application number: ANDA203437

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	863025af-2b71-477d-baa9-3ce7f435e385	6
317094	entacapone 200 MG Oral Tablet	SCD	863025af-2b71-477d-baa9-3ce7f435e385	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6822-04	00904682204	30 BLISTER PACK in 1 CARTON (0904-6822-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK	30 blister pack	2015-06-19	0000-00-00	No	No	Current
0904-6822-07	00904682207	30 BLISTER PACK in 1 CARTON (0904-6822-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK	30 blister pack	2024-05-02		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Entacapone Tablets, USP Rx only Prescribing Information	Major Pharmaceuticals	2025-09-10	HUMAN PRESCRIPTION DRUG LABEL	6