PIRFENIDONE

Product NDC: 69539-120
11-digit product format: 695390120
Labeler code: 69539
Product ID: 69539-120_f5870f41-5199-4791-859f-530c43b41eb9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PIRFENIDONE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: MSN LABORATORIES PRIVATE LIMITED
Application: ANDA212772
Marketing category: ANDA
Marketing start: 2022-05-24
Marketing end: 0000-00-00
Substance: PIRFENIDONE
Active strength: 801 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69539-120		D	Discontinued by firm	2026-08-03
excluded package	package	69539-120	69539-120-71	D	Discontinued by firm	2026-08-03
excluded package	package	69539-120	69539-120-90	D	Discontinued by firm	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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	69539-120		D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69539-120	69539-120-90	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69539-120	69539-120-71	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A212772-001	PIRFENIDONE	PIRFENIDONE	267MG	TABLET / ORAL	AB		2022-05-24
A212772-002	PIRFENIDONE	PIRFENIDONE	801MG	TABLET / ORAL	AB		2022-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212772-001	AB
A212772-002	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	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212772-001	PIRFENIDONE	267MG	TABLET / ORAL	AB	2022-05-24	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212772-002	PIRFENIDONE	801MG	TABLET / ORAL	AB	2022-05-24	`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	A212772-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212772-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212772-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212772-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212772-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212772-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212772-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212772-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212772-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212772-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212772-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212772-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212772-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212772-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212772-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212772-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212772-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212772-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212772-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212772-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212772-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212772-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212772-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212772-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212772-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212772-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212772-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212772-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212772-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212772-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212772-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212772-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212772-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A212772-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212772-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A212772-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212772-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212772-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212772-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212772-002	AB	1	`9b2671bbb829…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69539-120	PIRFENIDONE TABLET, FILM COATED [MSN LABORATORIES PRIVATE LIMITED]	5	Legacy NDC	20240724_a6c5ee89-ffb7-4eb1-a32c-e366981d2aac.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PIRFENIDONE	PIRFENIDONE	Novadoz Pharmaceuticals LLC	741d1b9c-e281-4eca-b327-e25e82313006	2024-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212772 application number: ANDA212772
PIRFENIDONE	PIRFENIDONE	Northstar Rx LLC	5d0eee8c-dc7d-4444-8684-e9c9335291c8	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212772 application number: ANDA212772
PIRFENIDONE	PIRFENIDONE	MAJOR PHARMACEUTICALS	73db516f-8c80-431f-8190-33081718cf8d	2023-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212772 application number: ANDA212772

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69539-120-71	69539012071	3 BOTTLE in 1 CARTON (69539-120-71) > 30 TABLET, FILM COATED in 1 BOTTLE (69539-120-30)	3 bottle	2022-05-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PIRFENIDONE	MSN LABORATORIES PRIVATE LIMITED \| MSN Pharmaceuticals Inc.	2024-07-23	Human Prescription Drug Label	5