Pirfenidone

Product NDC: 46708-479
11-digit product format: 467080479
Labeler code: 46708
Product ID: 46708-479_5dd2966d-35b0-4a80-a677-bca6f4c69311
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pirfenidone
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA212708
Marketing category: ANDA
Marketing start: 2022-06-10
Substance: PIRFENIDONE
Active strength: 267 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A212708-001	PIRFENIDONE	PIRFENIDONE	267MG	TABLET / ORAL	AB		2022-05-20
A212708-002	PIRFENIDONE	PIRFENIDONE	801MG	TABLET / ORAL	AB		2022-05-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212708-001	AB
A212708-002	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 · 58 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	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212708-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-20	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212708-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-20	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A212708-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212708-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212708-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212708-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212708-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212708-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212708-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212708-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212708-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212708-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212708-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212708-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212708-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212708-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212708-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212708-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212708-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212708-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212708-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212708-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212708-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212708-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212708-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212708-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212708-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212708-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212708-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212708-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212708-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212708-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212708-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212708-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212708-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212708-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212708-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212708-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212708-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212708-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212708-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212708-002	AB	1	`9b2671bbb829…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PIRFENIDONE	267 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
6e4f991a-c9e3-4121-97d0-d07954f17336	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	SPL version
46708-479-27	Pirfenidone	270 in 1 BOTTLE	TABLET, COATED	270	3
46708-479-64	Pirfenidone	3 in 1 CARTON	TABLET, COATED	3	3
46708-479-64	Pirfenidone	90 in 1 BOTTLE	TABLET, COATED	90	3
46708-479-71	Pirfenidone	500 in 1 BOTTLE	TABLET, COATED	500	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-479	PIRFENIDONE TABLET, COATED [ALEMBIC PHARMACEUTICALS LIMITED]	3	Current NDC, 4 package rows	20230401_6e4f991a-c9e3-4121-97d0-d07954f17336.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pirfenidone	PIRFENIDONE	Bryant Ranch Prepack	33f1ca21-4c08-4103-889d-1d9c929b5fad	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212708 application number: ANDA212708
Pirfenidone	PIRFENIDONE	Bryant Ranch Prepack	bd3483bf-96e9-4d6b-a844-63bd002c48a4	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212708 application number: ANDA212708
Pirfenidone	PIRFENIDONE	Bryant Ranch Prepack	bfcb3157-cfa1-493d-9598-1e7fd3d355d9	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212708 application number: ANDA212708
Pirfenidone	PIRFENIDONE	Bryant Ranch Prepack	9bdc7ed9-e51c-4101-a792-31619f05136b	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212708 application number: ANDA212708
Pirfenidone	PIRFENIDONE	Alembic Pharmaceuticals Inc.	9214862e-9ef7-4370-856a-f5697978270a	2023-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212708 application number: ANDA212708
Pirfenidone	PIRFENIDONE	Alembic Pharmaceuticals Limited	6e4f991a-c9e3-4121-97d0-d07954f17336	2023-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212708 application number: ANDA212708 ndc (product): 46708-479

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	6e4f991a-c9e3-4121-97d0-d07954f17336	3
1868018	pirfenidone 801 MG Oral Tablet	PSN	6e4f991a-c9e3-4121-97d0-d07954f17336	3
1868014	pirfenidone 267 MG Oral Tablet	SCD	6e4f991a-c9e3-4121-97d0-d07954f17336	3
1868018	pirfenidone 801 MG Oral Tablet	SCD	6e4f991a-c9e3-4121-97d0-d07954f17336	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
46708-479-27	46708047927	270 TABLET, COATED in 1 BOTTLE (46708-479-27)		2022-11-22	No	No	Current
46708-479-64	46708047964	3 BOTTLE in 1 CARTON (46708-479-64) / 90 TABLET, COATED in 1 BOTTLE	3 bottle	2022-06-10	No	No	Current
46708-479-71	46708047971	500 TABLET, COATED in 1 BOTTLE (46708-479-71)		2022-06-10	No	No	Current