ESBRIET

Product NDC: 50242-121
11-digit product format: 502420121
Labeler code: 50242
Product ID: 50242-121_b7cd3ccc-b1a4-4156-89cb-be9caccd16d3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PIRFENIDONE
Dosage form: CAPSULE
Route: ORAL
Labeler: Genentech, Inc.
Application: NDA022535
Marketing category: NDA
Marketing start: 2014-10-15
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50242-121		D	Discontinued by firm		2026-08-07
excluded package	package	50242-121	50242-121-01	D	Discontinued by firm		2026-08-07

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50242-121-01	2024-01-30	C162847	48780-1	1030e365-6cc7-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use ESBRIET safely and effectively. See full prescribing information for ESBRIET. ESBRIET ® (pirfenidone) capsules and film-coated tablets, for oral use Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50242-121-01	ESBRIET	270 in 1 BOTTLE, PLASTIC	CAPSULE	270		21
50242-121-01	ESBRIET	1 in 1 CARTON	CAPSULE	1		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50242-121-01	EA - Each	50242-121	98e4e29c-1cd7-4ba0-9874-4cfad4bd4bee	1	2016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PIRFENIDONE	ACTIVE INGREDIENT	D7NLD2JX7U	ESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]	1
PIRFENIDONE	ACTIVE MOIETY	D7NLD2JX7U	ESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESBRIET (PIRFENIDONE) CAPSULE [GENENTECH, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50242-121	ESBRIET (PIRFENIDONE) CAPSULE ESBRIET (PIRFENIDONE) TABLET, COATED [GENENTECH, INC.]	17	Legacy NDC, 2 package rows	20241122_2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e.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 · 1 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 ndc (product): 50242-121

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	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1868016	Esbriet 267 MG Oral Tablet	PSN	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1868020	Esbriet 801 MG Oral Tablet	PSN	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1592279	pirfenidone 267 MG Oral Capsule	PSN	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1868014	pirfenidone 267 MG Oral Tablet	PSN	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1868018	pirfenidone 801 MG Oral Tablet	PSN	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1592285	pirfenidone 267 MG Oral Capsule [Esbriet]	SBD	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1868016	pirfenidone 267 MG Oral Tablet [Esbriet]	SBD	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1868020	pirfenidone 801 MG Oral Tablet [Esbriet]	SBD	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1592279	pirfenidone 267 MG Oral Capsule	SCD	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1868014	pirfenidone 267 MG Oral Tablet	SCD	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1868018	pirfenidone 801 MG Oral Tablet	SCD	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1592285	Esbriet 267 MG Oral Capsule	SY	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1868016	Esbriet 267 MG Oral Tablet	SY	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21
1868020	Esbriet 801 MG Oral Tablet	SY	2e8c3537-36d7-4de5-9b5c-7a624b9a9e6e	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50242-121-01	50242012101	1 BOTTLE, PLASTIC in 1 CARTON (50242-121-01) > 270 CAPSULE in 1 BOTTLE, PLASTIC	2014-10-15	0000-00-00	No	No	Current