Entacapone

Product NDC: 55648-781
11-digit product format: 556480781
Labeler code: 55648
Product ID: 55648-781_db131736-7c7c-4f65-b2ee-b3d5f8e76ead
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Entacapone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Wockhardt Limited
Application: NDA020796
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2012-09-30
Marketing end: 0000-00-00
Substance: ENTACAPONE
Active strength: 200 mg/1
Pharmacologic classes: Catechol O-Methyltransferase Inhibitors [MoA],Catechol-O-Methyltransferase Inhibitor [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55648-781		I	Inactivated by FDA	2026-08-17
excluded package	package	55648-781	55648-781-02	I	Inactivated by FDA	2026-08-17
excluded package	package	55648-781	55648-781-03	I	Inactivated by FDA	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 2 · 66 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	55648-781-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55648-781-03	`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	55648-781-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55648-781-03	`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	55648-781-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55648-781-03	`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	55648-781-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55648-781-03	`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	55648-781-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55648-781-03	`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	55648-781-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55648-781-03	`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	55648-781-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55648-781-03	`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	55648-781-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55648-781-03	`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	55648-781-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55648-781-03	`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	55648-781-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55648-781-03	`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	55648-781-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55648-781-03	`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	55648-781-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55648-781-03	`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	55648-781-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	55648-781-03	`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	55648-781-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	55648-781-03	`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	55648-781-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	55648-781-03	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55648-781-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	55648-781-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55648-781-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	55648-781-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55648-781-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	55648-781-03	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55648-781-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	55648-781-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55648-781-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	55648-781-03	`e2bbac7714bc…`	`27bdfed8d636…`

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
N020796-001	COMTAN	ENTACAPONE	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020796-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020796-001	COMTAN	200MG	TABLET / ORAL	AB	RLD, RS	1999-10-19	`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	N020796-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020796-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020796-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020796-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020796-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020796-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020796-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020796-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020796-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020796-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020796-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020796-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020796-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020796-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020796-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020796-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020796-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020796-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020796-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020796-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020796-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020796-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020796-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020796-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020796-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020796-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020796-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020796-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020796-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020796-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020796-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020796-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020796-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020796-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020796-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020796-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020796-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020796-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020796-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020796-001	AB	1	`e64feba35796…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55648-781-02	2020-01-31	C162847	48780-1	9d75b9d0-2be4-f424-e053-dadaa90a57ce	Entacapone Tablets
55648-781-03	2020-01-31	C162847	48780-1	9d75b9d0-2be4-f424-e053-dadaa90a57ce	Entacapone Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55648-781-02	Entacapone	1 in 1 CARTON	TABLET, FILM COATED	1	1
55648-781-02	Entacapone	100 in 1 BOTTLE	TABLET, FILM COATED	100	1
55648-781-03	Entacapone	500 in 1 BOTTLE	TABLET, FILM COATED	500	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ENTACAPONE	ACTIVE INGREDIENT	4975G9NM6T	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
ENTACAPONE	ACTIVE MOIETY	4975G9NM6T	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55648-781	ENTACAPONE TABLET, FILM COATED [WOCKHARDT LIMITED]	1	Legacy NDC, 3 package rows	20120930_5a68fa36-ed25-4309-8624-cd6a0001ec7f.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
Entacapone	ENTACAPONE	Sandoz Inc	ad4b6d79-efd3-4c43-b4dc-5afdacf939a4	2023-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020796 application number: NDA020796
Entacapone	ENTACAPONE	Aphena Pharma Solutions - Tennessee, LLC	32d30f97-ae0f-4d02-bdd7-75e0783d66bc	2019-03-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020796 application number: NDA020796
Entacapone	ENTACAPONE	Sun Pharmaceutical Industries, Inc.	205522fb-bb0e-414e-a413-a08bef727653	2018-10-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020796 application number: NDA020796

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	5a68fa36-ed25-4309-8624-cd6a0001ec7f	1
317094	entacapone 200 MG Oral Tablet	SCD	5a68fa36-ed25-4309-8624-cd6a0001ec7f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
55648-781-02	55648078102	1 in 1 CARTON	Historical
55648-781-03	55648078103	500 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Entacapone Tablets	Wockhardt Limited \| Orion Corporation, Orion Pharma	2012-09-03	HUMAN PRESCRIPTION DRUG LABEL	1