Fenofibrate

Product NDC: 69844-009
11-digit product format: 698440009
Labeler code: 69844
Product ID: 69844-009_ef12b8d9-a584-4ab2-e053-2995a90ad8ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fenofibrate
Dosage form: TABLET
Route: ORAL
Labeler: Graviti Pharmaceuticals Private Limited
Application: ANDA210606
Marketing category: ANDA
Marketing start: 2018-08-17
Marketing end: 0000-00-00
Substance: FENOFIBRATE
Active strength: 160 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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
A210606-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2018-08-17
A210606-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2018-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210606-001	AB
A210606-002	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 3 · 82 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	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL		2018-08-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL		2018-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210606-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-08-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210606-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-08-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 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	A210606-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210606-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210606-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210606-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210606-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210606-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210606-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210606-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210606-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210606-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210606-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210606-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210606-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210606-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210606-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210606-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210606-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210606-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210606-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210606-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210606-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210606-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210606-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210606-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210606-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210606-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210606-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210606-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210606-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210606-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210606-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210606-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210606-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210606-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210606-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210606-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210606-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210606-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210606-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210606-002	AB	1	`87673890dc5c…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibrate	FENOFIBRATE	Leading Pharma, LLC	f73a40ef-1513-4a07-a5a9-51efb30bf560	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210606 application number: ANDA210606
FENOFIBRATE	FENOFIBRATE	Laurus Labs Limited	8e58c13a-8088-4fed-86cc-52530de5aa45	2022-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210606 application number: ANDA210606

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U202363UOS	FENOFIBRATE	49562-28-9	FENOFIBRATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69844-009-01	69844000901	30 TABLET in 1 BOTTLE (69844-009-01)	30 tablet	2018-08-17	0000-00-00	No	No	Current
69844-009-02	69844000902	90 TABLET in 1 BOTTLE (69844-009-02)	90 tablet	2018-08-17	0000-00-00	No	No	Current
69844-009-03	69844000903	1000 TABLET in 1 BOTTLE (69844-009-03)	1000 tablet	2018-08-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibrate film coated	Graviti Pharmaceuticals Private Limited	2022-12-05	HUMAN PRESCRIPTION DRUG LABEL	13