Comtan

Product NDC: 0078-0327
11-digit product format: 000780327
Labeler code: 0078
Product ID: 0078-0327_82fdf87b-0cad-4f0b-900e-500e481a2d6b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: entacapone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA020796
Marketing category: NDA
Marketing start: 1999-10-19
Marketing end: 2022-04-30
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: 0000-00-00
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	0078-0327		D	Discontinued by firm		2026-08-17
excluded package	package	0078-0327	0078-0327-05	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 · 24 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	0078-0327-05	`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	0078-0327-05	`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	0078-0327-05	`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	0078-0327-05	`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	0078-0327-05	`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	0078-0327-05	`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	0078-0327-05	`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	0078-0327-05	`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	0078-0327-05	`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	0078-0327-05	`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	0078-0327-05	`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	0078-0327-05	`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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0327-05	EA - Each	0078-0327	e1593f63-0a3d-4e17-a1ee-397086866830	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ENTACAPONE	ACTIVE INGREDIENT	4975G9NM6T	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
ENTACAPONE	ACTIVE MOIETY	4975G9NM6T	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
HYDROGENATED COTTONSEED OIL	INACTIVE INGREDIENT	Z82Y2C65EA	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
SUCROSE	INACTIVE INGREDIENT	C151H8M554	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	COMTAN (ENTACAPONE) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	9

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0327-05	00078032705	100 TABLET, FILM COATED in 1 BOTTLE (0078-0327-05)	1999-10-19	2022-04-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COMTAN ® (entacapone) Tablets	Novartis Pharmaceuticals Corporation \| Packaging Coordinators LLC \| Lunaria spol.s.r.o \| Eurofins Lancaster Laboratories, Inc. \| Orion Corporation, Orion Pharma	2020-12-02	HUMAN PRESCRIPTION DRUG LABEL	16