Pirfenidone

Product NDC: 0480-3611
Requested package NDC: 0480-3611-00
11-digit product format: 004803611
Labeler code: 0480
Product ID: 0480-3611_eb41bb72-1c2a-4c39-80a6-c09f3bf897fb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pirfenidone
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals, Inc.
Application: ANDA212759
Marketing category: ANDA
Marketing start: 2022-05-11
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	0480-3611	0480-3611-00	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212759-001	PIRFENIDONE	PIRFENIDONE	267MG	TABLET / ORAL	AB		2022-01-25
A212759-002	PIRFENIDONE	PIRFENIDONE	801MG	TABLET / ORAL	AB		2022-01-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212759-001	AB
A212759-002	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 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212759-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-01-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212759-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-01-25	`1c564ffb4f44…`

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	A212759-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212759-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212759-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212759-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212759-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212759-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212759-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212759-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212759-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212759-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212759-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212759-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212759-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212759-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212759-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212759-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212759-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212759-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212759-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212759-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212759-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212759-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212759-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212759-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212759-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212759-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212759-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212759-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212759-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212759-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212759-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212759-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212759-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212759-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212759-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212759-002	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212759-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212759-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212759-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212759-002	AB	1	`1c564ffb4f44…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pirfenidone
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1868014	Internal RxNorm lookup
1868018	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
cbbd14a4-b7e6-4147-9314-bb715dfb1a51	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0480-3611-98	Pirfenidone	90 in 1 BOTTLE	TABLET, FILM COATED	90		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0480-3611-98	EA - Each	0480-3611	144938f8-91bd-4d1e-aa17-52747bdce580	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0480-3611	PIRFENIDONE TABLET, FILM COATED [TEVA PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20250321_cbbd14a4-b7e6-4147-9314-bb715dfb1a51.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
Pirfenidone	PIRFENIDONE	Teva Pharmaceuticals, Inc.	cbbd14a4-b7e6-4147-9314-bb715dfb1a51	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212759 application number: ANDA212759 ndc (product): 0480-3611

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
1868014	pirfenidone 267 MG Oral Tablet	PSN	cbbd14a4-b7e6-4147-9314-bb715dfb1a51	5
1868018	pirfenidone 801 MG Oral Tablet	PSN	cbbd14a4-b7e6-4147-9314-bb715dfb1a51	5
1868014	pirfenidone 267 MG Oral Tablet	SCD	cbbd14a4-b7e6-4147-9314-bb715dfb1a51	5
1868018	pirfenidone 801 MG Oral Tablet	SCD	cbbd14a4-b7e6-4147-9314-bb715dfb1a51	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
0480-3611-00	00480361100	10000 TABLET, FILM COATED in 1 BOX (0480-3611-00)	11-MAY-22	Current