ESBRIET

Product NDC: 83107-029
11-digit product format: 831070029
Labeler code: 83107
Product ID: 83107-029_372827fa-ccfe-42b6-e063-6394a90af5e8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PIRFENIDONE
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Legacy Pharma USA Inc.
Application: NDA208780
Marketing category: NDA
Marketing start: 2025-05-31
Substance: PIRFENIDONE
Active strength: 801 mg/1
Pharmacologic classes: Pyridone [EPC], Pyridones [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208780-001	ESBRIET	PIRFENIDONE	267MG	TABLET / ORAL	AB	RLD	2017-01-11
N208780-002	ESBRIET	PIRFENIDONE	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11
N208780-003	ESBRIET	PIRFENIDONE	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N208780-001	AB
N208780-003	AB

Orange Book patents#

Current patent rows page 1 of 2 · 129 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208780-001	7767700	2027-12-18	U-2080		2017-02-10
N208780-001	8420674	2027-12-18	U-2079		2017-02-10
N208780-001	8383150	2028-05-10	U-2361	Drug product	2017-02-10
N208780-001	7566729	2029-04-22	U-2077		2017-02-10
N208780-001	7566729	2029-04-22	U-2078		2017-02-10
N208780-001	7635707	2029-04-22	U-2072		2017-02-10
N208780-001	7635707	2029-04-22	U-2073		2017-02-10
N208780-001	7635707	2029-04-22	U-2074		2017-02-10
N208780-001	7635707	2029-04-22	U-2075		2017-02-10
N208780-001	7635707	2029-04-22	U-2076		2017-02-10
N208780-001	7635707	2029-04-22	U-2083		2017-02-10
N208780-001	8592462	2029-04-22	U-2055		2017-02-10
N208780-001	8592462	2029-04-22	U-2056		2017-02-10
N208780-001	8592462	2029-04-22	U-2057		2017-02-10
N208780-001	8592462	2029-04-22	U-2058		2017-02-10
N208780-001	8592462	2029-04-22	U-2059		2017-02-10
N208780-001	8592462	2029-04-22	U-2060		2017-02-10
N208780-001	8592462	2029-04-22	U-2061		2017-02-10
N208780-001	8592462	2029-04-22	U-2062		2017-02-10
N208780-001	8592462	2029-04-22	U-2063		2017-02-10
N208780-001	8609701	2029-04-22	U-2064		2017-02-10
N208780-001	8609701	2029-04-22	U-2065		2017-02-10
N208780-001	8609701	2029-04-22	U-2066		2017-02-10
N208780-001	8609701	2029-04-22	U-2067		2017-02-10
N208780-001	8609701	2029-04-22	U-2068		2017-02-10
N208780-001	8609701	2029-04-22	U-2069		2017-02-10
N208780-001	8609701	2029-04-22	U-2070		2017-02-10
N208780-001	7816383	2030-01-08	U-2042		2017-02-10
N208780-001	7816383	2030-01-08	U-2050		2017-02-10
N208780-001	7910610	2030-01-08	U-2048		2017-02-10
N208780-001	7910610	2030-01-08	U-2049		2017-02-10
N208780-001	8013002	2030-01-08	U-2047		2017-02-10
N208780-001	8013002	2030-01-08	U-2082		2017-02-10
N208780-001	8084475	2030-01-08	U-2052		2017-02-10
N208780-001	8084475	2030-01-08	U-2054		2017-02-10
N208780-001	8318780	2030-01-08	U-2046		2017-02-10
N208780-001	8318780	2030-01-08	U-2081		2017-02-10
N208780-001	8648098	2030-01-08	U-2051		2017-02-10
N208780-001	8648098	2030-01-08	U-2052		2017-02-10
N208780-001	8754109	2030-01-08	U-2053		2017-02-10
N208780-001	8778947	2033-08-30	U-2044		2017-02-10
N208780-001	8778947	2033-08-30	U-2045		2017-02-10
N208780-001	10188637	2037-03-28		Drug product	2019-02-25
N208780-002	7767700	2027-12-18	U-2080		2018-03-08
N208780-002	8420674	2027-12-18	U-2079		2018-03-08
N208780-002	8383150	2028-05-10	U-2361	Drug product	2018-03-08
N208780-002	7566729	2029-04-22	U-2269		2018-03-08
N208780-002	7566729	2029-04-22	U-2270		2018-03-08
N208780-002	7635707	2029-04-22	U-2072		2018-03-08
N208780-002	7635707	2029-04-22	U-2073		2018-03-08
N208780-002	7635707	2029-04-22	U-2074		2018-03-08
N208780-002	7635707	2029-04-22	U-2075		2018-03-08
N208780-002	7635707	2029-04-22	U-2076		2018-03-08
N208780-002	7635707	2029-04-22	U-2083		2018-03-08
N208780-002	8592462	2029-04-22	U-2055		2018-03-08
N208780-002	8592462	2029-04-22	U-2056		2018-03-08
N208780-002	8592462	2029-04-22	U-2057		2018-03-08
N208780-002	8592462	2029-04-22	U-2058		2018-03-08
N208780-002	8592462	2029-04-22	U-2059		2018-03-08
N208780-002	8592462	2029-04-22	U-2060		2018-03-08
N208780-002	8592462	2029-04-22	U-2061		2018-03-08
N208780-002	8592462	2029-04-22	U-2062		2018-03-08
N208780-002	8592462	2029-04-22	U-2063		2018-03-08
N208780-002	8609701	2029-04-22	U-2064		2018-03-08
N208780-002	8609701	2029-04-22	U-2065		2018-03-08
N208780-002	8609701	2029-04-22	U-2066		2018-03-08
N208780-002	8609701	2029-04-22	U-2067		2018-03-08
N208780-002	8609701	2029-04-22	U-2068		2018-03-08
N208780-002	8609701	2029-04-22	U-2069		2018-03-08
N208780-002	8609701	2029-04-22	U-2070		2018-03-08
N208780-002	7816383	2030-01-08	U-2042		2018-03-08
N208780-002	7816383	2030-01-08	U-2050		2018-03-08
N208780-002	7910610	2030-01-08	U-2048		2018-03-08
N208780-002	7910610	2030-01-08	U-2049		2018-03-08
N208780-002	8013002	2030-01-08	U-2047		2018-03-08
N208780-002	8013002	2030-01-08	U-2082		2018-03-08
N208780-002	8084475	2030-01-08	U-2054		2018-03-08
N208780-002	8084475	2030-01-08	U-2268		2018-03-08
N208780-002	8318780	2030-01-08	U-2046		2018-03-08
N208780-002	8318780	2030-01-08	U-2081		2018-03-08

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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208780-002	ESBRIET	534MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2017-01-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208780-003	ESBRIET	801MG	TABLET / ORAL	AB	RLD, RS	2017-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208780-001	ESBRIET	267MG	TABLET / ORAL	AB	RLD	2017-01-11	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	N208780-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208780-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208780-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208780-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208780-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208780-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208780-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208780-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208780-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208780-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208780-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208780-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208780-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208780-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208780-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208780-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208780-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208780-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208780-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208780-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208780-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208780-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208780-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208780-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208780-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208780-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208780-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208780-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208780-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208780-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208780-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208780-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208780-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208780-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208780-003	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208780-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208780-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208780-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N208780-003	AB	1	`1c564ffb4f44…`

Observed Orange Book patent history#

Patent history page 1 of 134 · 5,343 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208780-001	7767700	2027-12-18	U-2080		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8420674	2027-12-18	U-2079		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8383150	2028-05-10	U-2361	Drug product	2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7566729	2029-04-22	U-2078		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7566729	2029-04-22	U-2077		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7635707	2029-04-22	U-2083		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7635707	2029-04-22	U-2074		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7635707	2029-04-22	U-2072		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7635707	2029-04-22	U-2075		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7635707	2029-04-22	U-2076		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7635707	2029-04-22	U-2073		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2060		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2063		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2056		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2058		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2057		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2059		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2061		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2055		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8592462	2029-04-22	U-2062		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2065		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2069		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2066		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2067		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2068		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2070		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8609701	2029-04-22	U-2064		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7816383	2030-01-08	U-2042		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7816383	2030-01-08	U-2050		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7910610	2030-01-08	U-2049		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	7910610	2030-01-08	U-2048		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8013002	2030-01-08	U-2047		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8013002	2030-01-08	U-2082		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8084475	2030-01-08	U-2052		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8084475	2030-01-08	U-2054		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8318780	2030-01-08	U-2046		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8318780	2030-01-08	U-2081		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8648098	2030-01-08	U-2051		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8648098	2030-01-08	U-2052		2017-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208780-001	8754109	2030-01-08	U-2053		2017-02-10	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N208780-001	NCE	2019-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208780-001	ODE-77	2021-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208780-002	NCE	2019-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208780-002	ODE-77	2021-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208780-003	NCE	2019-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208780-003	ODE-77	2021-10-15	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N208780-001	ODE-77	2021-10-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208780-002	ODE-77	2021-10-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208780-003	ODE-77	2021-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208780-001	ODE-77	2021-10-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208780-002	ODE-77	2021-10-15	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208780-003	ODE-77	2021-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208780-001	ODE-77	2021-10-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208780-002	ODE-77	2021-10-15	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208780-003	ODE-77	2021-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208780-001	ODE-77	2021-10-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208780-002	ODE-77	2021-10-15	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208780-003	ODE-77	2021-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208780-001	ODE-77	2021-10-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208780-002	ODE-77	2021-10-15	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208780-003	ODE-77	2021-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208780-001	NCE	2019-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208780-001	ODE-77	2021-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208780-002	NCE	2019-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208780-002	ODE-77	2021-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208780-003	NCE	2019-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208780-003	ODE-77	2021-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208780-001	NCE	2019-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208780-001	ODE-77	2021-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208780-002	NCE	2019-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208780-002	ODE-77	2021-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208780-003	NCE	2019-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208780-003	ODE-77	2021-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208780-001	NCE	2019-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208780-001	ODE-77	2021-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208780-002	NCE	2019-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208780-002	ODE-77	2021-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208780-003	NCE	2019-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208780-003	ODE-77	2021-10-15	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIRFENIDONE	801 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
D7NLD2JX7U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1868014	Internal RxNorm lookup
1868016	Internal RxNorm lookup
1868018	Internal RxNorm lookup
1868020	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
81f17f7d-cb04-4052-8682-dd3e330210ab	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
82ab2cd4-4ada-41b1-950d-75fef25f7bac	Product name	3	20250818
d62f4d7c-9247-4aa4-ad93-12349422d49e	Product name	2	20240530
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83107-029-90	ESBRIET	1 in 1 CARTON	TABLET, COATED	1		1
83107-029-90	ESBRIET	90 in 1 BOTTLE, PLASTIC	TABLET, COATED	90		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83107-029-90	EA - Each	83107-029	9fa2f9af-e42f-42db-ac32-6502fd5a0c51	1	2025-11-13

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
ESBRIET	PIRFENIDONE	Genentech, Inc.	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208780 application number: NDA208780
ESBRIET	PIRFENIDONE	Legacy Pharma USA Inc.	81f17f7d-cb04-4052-8682-dd3e330210ab	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208780 application number: NDA208780 ndc (product): 83107-029

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D7NLD2JX7U	PIRFENIDONE	53179-13-8	PIRFENIDONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1868016	Esbriet 267 MG Oral Tablet	PSN	81f17f7d-cb04-4052-8682-dd3e330210ab	1
1868020	Esbriet 801 MG Oral Tablet	PSN	81f17f7d-cb04-4052-8682-dd3e330210ab	1
1868014	pirfenidone 267 MG Oral Tablet	PSN	81f17f7d-cb04-4052-8682-dd3e330210ab	1
1868018	pirfenidone 801 MG Oral Tablet	PSN	81f17f7d-cb04-4052-8682-dd3e330210ab	1
1868016	pirfenidone 267 MG Oral Tablet [Esbriet]	SBD	81f17f7d-cb04-4052-8682-dd3e330210ab	1
1868020	pirfenidone 801 MG Oral Tablet [Esbriet]	SBD	81f17f7d-cb04-4052-8682-dd3e330210ab	1
1868014	pirfenidone 267 MG Oral Tablet	SCD	81f17f7d-cb04-4052-8682-dd3e330210ab	1
1868018	pirfenidone 801 MG Oral Tablet	SCD	81f17f7d-cb04-4052-8682-dd3e330210ab	1
1868016	Esbriet 267 MG Oral Tablet	SY	81f17f7d-cb04-4052-8682-dd3e330210ab	1
1868020	Esbriet 801 MG Oral Tablet	SY	81f17f7d-cb04-4052-8682-dd3e330210ab	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
83107-029-90	83107002990	1 BOTTLE, PLASTIC in 1 CARTON (83107-029-90) / 90 TABLET, COATED in 1 BOTTLE, PLASTIC	2025-06-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ESBRIET	Legacy Pharma USA Inc. \| Ferndale Laboratories, Inc.	2025-06-09	HUMAN PRESCRIPTION DRUG LABEL	1