FENOFIBRIC ACID DELAYED-RELEASE

Product NDC: 69844-023
11-digit product format: 698440023
Labeler code: 69844
Product ID: 69844-023_ef1386ae-152d-95cc-e053-2995a90a3053
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibric Acid
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Graviti Pharmaceuticals Private Limited
Application: ANDA211626
Marketing category: ANDA
Marketing start: 2019-07-18
Marketing end: 0000-00-00
Substance: FENOFIBRIC ACID
Active strength: 135 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
A211626-001	FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB		2019-07-18
A211626-002	FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB		2019-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211626-001	AB
A211626-002	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 · 80 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	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211626-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211626-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2019-07-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A211626-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211626-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211626-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211626-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211626-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211626-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211626-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211626-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211626-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211626-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211626-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211626-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211626-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211626-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211626-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211626-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211626-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211626-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211626-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211626-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211626-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211626-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211626-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211626-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211626-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211626-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211626-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211626-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211626-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211626-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211626-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211626-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211626-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211626-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211626-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211626-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211626-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211626-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211626-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211626-002	AB	1	`782e0a99824c…`

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
FENOFIBRIC ACID	FENOFIBRIC ACID	Leading Pharma, LLC	daa488be-f580-430c-a72c-80ac31bb3e40	2025-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211626 application number: ANDA211626
FENOFIBRIC ACID DELAYED-RELEASE	FENOFIBRIC ACID	Laurus Labs Limited	302ffbf8-448e-4729-949f-40d457e30ab4	2022-12-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211626 application number: ANDA211626

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
BGF9MN2HU1	FENOFIBRIC ACID	42017-89-0	FENOFIBRIC ACID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69844-023-01	69844002301	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69844-023-01)	2019-07-18	0000-00-00	No	No	Current
69844-023-02	69844002302	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69844-023-02)	2019-07-18	0000-00-00	No	No	Current
69844-023-03	69844002303	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (69844-023-03)	2019-07-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FENOFIBRIC ACID DELAYED-RELEASE	Graviti Pharmaceuticals Private Limited	2022-12-05	HUMAN PRESCRIPTION DRUG LABEL	13