Esbriet

Product NDC: 64116-121
11-digit product format: 641160121
Labeler code: 64116
Product ID: 64116-121_58cc9885-2828-435d-9db2-8e94cdecfa00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pirfenidone
Dosage form: CAPSULE
Route: ORAL
Labeler: InterMune, Inc.
Application: NDA022535
Marketing category: NDA
Marketing start: 2014-10-16
Marketing end: 0000-00-00
Substance: PIRFENIDONE
Active strength: 267 mg/1
Pharmacologic classes: Pyridone [EPC],Pyridones [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	64116-121		I	Inactivated by FDA	2026-08-07
excluded package	package	64116-121	64116-121-01	I	Inactivated by FDA	2026-08-07
excluded package	package	64116-121	64116-121-02	I	Inactivated by FDA	2026-08-07
excluded package	package	64116-121	64116-121-03	I	Inactivated by FDA	2026-08-07

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 · 84 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	64116-121-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64116-121-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64116-121-03	`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	64116-121-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64116-121-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64116-121-03	`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	64116-121-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64116-121-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64116-121-03	`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	64116-121-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64116-121-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64116-121-03	`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	64116-121-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64116-121-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64116-121-03	`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	64116-121-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64116-121-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64116-121-03	`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	64116-121-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64116-121-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64116-121-03	`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	64116-121-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64116-121-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64116-121-03	`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	64116-121-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64116-121-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64116-121-03	`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	64116-121-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64116-121-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64116-121-03	`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	64116-121-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64116-121-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64116-121-03	`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	64116-121-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64116-121-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64116-121-03	`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	64116-121-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64116-121-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64116-121-03	`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	64116-121-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64116-121-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64116-121-03	`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	64116-121-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64116-121-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64116-121-03	`1332a3947898…`	`d4bfe170f9cd…`

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

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
N022535-001	ESBRIET	PIRFENIDONE	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022535-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 19 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022535-001	7767225	2026-09-22	U-1602	Drug product	2014-11-14
N022535-001	7988994	2026-09-22	U-1602	Drug product	2014-11-14
N022535-001	8753679	2026-09-22	U-1602	Drug product	2014-11-14
N022535-001	7696236	2027-12-18	U-1601		2014-11-14
N022535-001	7767700	2027-12-18	U-1601		2014-11-14
N022535-001	8420674	2027-12-18	U-1608	Drug product	2014-11-14
N022535-001	8383150	2028-05-10	U-2361	Drug product	2014-11-14
N022535-001	7566729	2029-04-22	U-1600		2014-11-14
N022535-001	7635707	2029-04-22	U-1609		2014-11-14
N022535-001	8592462	2029-04-22	U-1609		2014-11-14
N022535-001	8609701	2029-04-22	U-1610		2014-11-14
N022535-001	7816383	2030-01-08	U-1603		2014-11-14
N022535-001	7910610	2030-01-08	U-1604		2014-11-14
N022535-001	8013002	2030-01-08	U-1603		2014-11-14
N022535-001	8084475	2030-01-08	U-1605		2014-11-14
N022535-001	8318780	2030-01-08	U-1606		2014-11-14
N022535-001	8648098	2030-01-08	U-1611		2014-11-14
N022535-001	8754109	2030-01-08	U-1612		2014-11-14
N022535-001	8778947	2033-08-30	U-1613		2014-11-14

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 · 41 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	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022535-001	ESBRIET	267MG	CAPSULE / ORAL		RLD, RS	2014-10-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022535-001	ESBRIET	267MG	CAPSULE / ORAL	AB	RLD, RS	2014-10-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022535-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022535-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022535-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022535-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022535-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022535-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022535-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022535-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022535-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022535-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022535-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022535-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022535-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022535-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022535-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022535-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022535-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022535-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022535-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022535-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022535-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022535-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022535-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022535-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022535-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022535-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022535-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022535-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022535-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022535-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022535-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 782 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	N022535-001	7767225	2026-09-22	U-1602	Drug product	2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7988994	2026-09-22	U-1602	Drug product	2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8753679	2026-09-22	U-1602	Drug product	2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7696236	2027-12-18	U-1601		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7767700	2027-12-18	U-1601		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8420674	2027-12-18	U-1608	Drug product	2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8383150	2028-05-10	U-2361	Drug product	2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7566729	2029-04-22	U-1600		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7635707	2029-04-22	U-1609		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8592462	2029-04-22	U-1609		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8609701	2029-04-22	U-1610		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7816383	2030-01-08	U-1603		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	7910610	2030-01-08	U-1604		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8013002	2030-01-08	U-1603		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8084475	2030-01-08	U-1605		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8318780	2030-01-08	U-1606		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8648098	2030-01-08	U-1611		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8754109	2030-01-08	U-1612		2014-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022535-001	8778947	2033-08-30	U-1613		2014-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7767225	2026-09-22	U-1602	Drug product	2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7988994	2026-09-22	U-1602	Drug product	2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8753679	2026-09-22	U-1602	Drug product	2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7696236	2027-12-18	U-1601		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7767700	2027-12-18	U-1601		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8420674	2027-12-18	U-1608	Drug product	2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8383150	2028-05-10	U-2361	Drug product	2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7566729	2029-04-22	U-1600		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7635707	2029-04-22	U-1609		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8592462	2029-04-22	U-1609		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8609701	2029-04-22	U-1610		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7816383	2030-01-08	U-1603		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	7910610	2030-01-08	U-1604		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8013002	2030-01-08	U-1603		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8084475	2030-01-08	U-1605		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8318780	2030-01-08	U-1606		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8648098	2030-01-08	U-1611		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8754109	2030-01-08	U-1612		2014-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022535-001	8778947	2033-08-30	U-1613		2014-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022535-001	7767225	2026-09-22	U-1602	Drug product	2014-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022535-001	7988994	2026-09-22	U-1602	Drug product	2014-11-14	`6a471c1ec25d…`

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	N022535-001	NCE	2019-10-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022535-001	ODE-77	2021-10-15	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022535-001	ODE-77	2021-10-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022535-001	ODE-77	2021-10-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022535-001	ODE-77	2021-10-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022535-001	ODE-77	2021-10-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022535-001	ODE-77	2021-10-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022535-001	NCE	2019-10-15	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022535-001	ODE-77	2021-10-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022535-001	NCE	2019-10-15	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022535-001	ODE-77	2021-10-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022535-001	NCE	2019-10-15	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022535-001	ODE-77	2021-10-15	`ea99ee380514…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64116-121-01	2020-01-31	C162847	48780-1	9d75b9d0-0d21-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET ® (pirfenidone) capsules, for oral use Initial U.S. Approval: 2014
64116-121-02	2020-01-31	C162847	48780-1	9d75b9d0-0d21-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET ® (pirfenidone) capsules, for oral use Initial U.S. Approval: 2014
64116-121-03	2020-01-31	C162847	48780-1	9d75b9d0-0d21-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET ® (pirfenidone) capsules, for oral use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64116-121-01	Esbriet	270 in 1 BOTTLE, PLASTIC	CAPSULE	270	1
64116-121-01	Esbriet	1 in 1 CARTON	CAPSULE	1	1
64116-121-02	Esbriet	1 in 1 CARTON	CAPSULE	1	1
64116-121-02	Esbriet	63 in 1 BLISTER PACK	CAPSULE	63	1
64116-121-03	Esbriet	4 in 1 CARTON	CAPSULE	4	1
64116-121-03	Esbriet	63 in 1 BLISTER PACK	CAPSULE	63	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64116-121-01	EA - Each	64116-121	07234943-854f-4547-8cf4-c5e59a94aebb	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PIRFENIDONE	ACTIVE INGREDIENT	D7NLD2JX7U	ESBRIET (PIRFENIDONE) CAPSULE [INTERMUNE, INC.]	1
PIRFENIDONE	ACTIVE MOIETY	D7NLD2JX7U	ESBRIET (PIRFENIDONE) CAPSULE [INTERMUNE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64116-121	ESBRIET (PIRFENIDONE) CAPSULE [INTERMUNE, INC.]	1	Legacy NDC, 6 package rows	20141028_0ab861c2-d5ca-4f92-854c-6477971a1b38.zip

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
1592285	Esbriet 267 MG Oral Capsule	PSN	0ab861c2-d5ca-4f92-854c-6477971a1b38	1
1592279	pirfenidone 267 MG Oral Capsule	PSN	0ab861c2-d5ca-4f92-854c-6477971a1b38	1
1592285	pirfenidone 267 MG Oral Capsule [Esbriet]	SBD	0ab861c2-d5ca-4f92-854c-6477971a1b38	1
1592279	pirfenidone 267 MG Oral Capsule	SCD	0ab861c2-d5ca-4f92-854c-6477971a1b38	1
1592285	Esbriet 267 MG Oral Capsule	SY	0ab861c2-d5ca-4f92-854c-6477971a1b38	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64116-121-01	64116012101	270 in 1 BOTTLE, PLASTIC	Historical
64116-121-02	64116012102	1 in 1 CARTON	Historical
64116-121-03	64116012103	4 in 1 CARTON	Historical