FENOFIBRIC ACID DELAYED-RELEASE

Product NDC: 42385-944
11-digit product format: 423850944
Labeler code: 42385
Product ID: 42385-944_f0e00f9f-65f5-407a-e053-2a95a90a260f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENOFIBRIC ACID
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Laurus Labs Limited
Application: ANDA211626
Marketing category: ANDA
Marketing start: 2020-08-24
Substance: FENOFIBRIC ACID
Active strength: 45 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: FENOFIBRIC ACID DELAYED-RELEASE
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENOFIBRIC ACID	45 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BGF9MN2HU1	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
828373	Internal RxNorm lookup
828379	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
302ffbf8-448e-4729-949f-40d457e30ab4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
193bb7da-5c03-8f95-9048-23ef403846b0	Product name	3	20250616
fa35fb9a-7146-716b-13c8-bc1f60030232	Product name	9	20250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07	Product name	8	20231212
53d5b6b7-785a-4500-9460-263c7f8424b8	Product name	5	20210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66	Product name	9	20200708

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42385-944-11	FENOFIBRIC ACID DELAYED-RELEASE	1000 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	1000	3
42385-944-30	FENOFIBRIC ACID DELAYED-RELEASE	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	3
42385-944-90	FENOFIBRIC ACID DELAYED-RELEASE	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42385-944-90	EA - Each	42385-944	058dfad0-6832-48bb-9346-639aebdbb961	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42385-944	FENOFIBRIC ACID DELAYED-RELEASE (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE FENOFIBRIC ACID DELAYED-RELEASE (FENOFIBRIC ACID) CAPSULE, DELAYED RELEASE [LAURUS LABS LIMITED]	3	Current NDC, Legacy NDC, 3 package rows	20221229_302ffbf8-448e-4729-949f-40d457e30ab4.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 · 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 ndc (product): 42385-944

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
828373	fenofibric acid 135 MG Delayed Release Oral Capsule	PSN	302ffbf8-448e-4729-949f-40d457e30ab4	3
828379	fenofibric acid 45 MG Delayed Release Oral Capsule	PSN	302ffbf8-448e-4729-949f-40d457e30ab4	3
828373	fenofibric acid 135 MG Delayed Release Oral Capsule	SCD	302ffbf8-448e-4729-949f-40d457e30ab4	3
828379	fenofibric acid 45 MG Delayed Release Oral Capsule	SCD	302ffbf8-448e-4729-949f-40d457e30ab4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42385-944-11	42385094411	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-944-11)	2020-08-24	0000-00-00	No	No	Current
42385-944-30	42385094430	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-944-30)	2020-08-24	0000-00-00	No	No	Current
42385-944-90	42385094490	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42385-944-90)	2020-08-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FENOFIBRIC ACID DELAYED-RELEASE	Laurus Labs Limited \| Graviti Pharmaceuticals Private Limited	2022-12-28	HUMAN PRESCRIPTION DRUG LABEL	3