FENOFIBRATE

Product NDC: 71335-0891
11-digit product format: 713350891
Labeler code: 71335
Product ID: 71335-0891_ee881909-c759-4817-a79b-a498e22c4eb8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FENOFIBRATE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA208709
Marketing category: ANDA
Marketing start: 2016-12-15
Substance: FENOFIBRATE
Active strength: 48 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
A208709-001	FENOFIBRATE	FENOFIBRATE	48MG	TABLET / ORAL	AB		2016-12-15
A208709-002	FENOFIBRATE	FENOFIBRATE	145MG	TABLET / ORAL	AB		2016-12-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208709-001	AB
A208709-002	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	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208709-001	FENOFIBRATE	48MG	TABLET / ORAL	AB	2016-12-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208709-002	FENOFIBRATE	145MG	TABLET / ORAL	AB	2016-12-15	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A208709-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208709-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208709-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208709-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208709-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208709-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208709-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208709-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208709-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208709-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208709-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208709-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208709-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208709-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208709-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208709-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208709-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208709-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208709-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208709-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208709-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208709-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208709-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208709-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208709-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208709-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208709-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208709-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208709-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208709-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208709-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208709-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208709-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208709-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208709-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208709-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208709-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208709-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208709-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208709-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: FENOFIBRATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENOFIBRATE	48 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U202363UOS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
477562	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
b11f1c74-23da-4273-b504-0a2ca22c4b5a	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
36a239c8-03fb-0083-81af-6c1afb195671	Product name	1	20140508
a0296d70-ca85-018c-84e8-cf3f630976b7	Product name	1	20140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372a	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0891-1	FENOFIBRATE	30 in 1 BOTTLE	TABLET	30	5
71335-0891-2	FENOFIBRATE	90 in 1 BOTTLE	TABLET	90	5
71335-0891-3	FENOFIBRATE	28 in 1 BOTTLE	TABLET	28	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0891	FENOFIBRATE TABLET [BRYANT RANCH PREPACK]	5	Current NDC, Legacy NDC, 3 package rows	20231122_b11f1c74-23da-4273-b504-0a2ca22c4b5a.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FENOFIBRATE	FENOFIBRATE	Bryant Ranch Prepack	b11f1c74-23da-4273-b504-0a2ca22c4b5a	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709 ndc (product): 71335-0891
FENOFIBRATE	FENOFIBRATE	Major Pharmaceuticals	bbffd586-f63a-4a84-bdfb-3e4a1df6449e	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	0178ea2e-2c79-b97b-e063-6394a90ac145	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
Fenofibrate	FENOFIBRATE	Northwind Health Company, LLC	f2b6e2a7-68d7-264d-e053-2a95a90aa9d1	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
Fenofibrate	FENOFIBRATE	Cipla USA Inc.	f8f09ab1-74db-4123-b85a-6337dc2582a0	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
FENOFIBRATE	FENOFIBRATE	NCS HealthCare of KY, LLC dba Vangard Labs	4d8a93cb-6d66-4251-bb33-37982525ac09	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
FENOFIBRATE	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	968e7f57-1360-ba5a-e053-2995a90a206c	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709
FENOFIBRATE	FENOFIBRATE	A-S Medication Solutions	734f72a2-96f7-4480-9a87-c1ffd94b5f0b	2023-07-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208709 application number: ANDA208709

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
477562	fenofibrate 48 MG Oral Tablet	PSN	b11f1c74-23da-4273-b504-0a2ca22c4b5a	6
477562	fenofibrate 48 MG Oral Tablet	SCD	b11f1c74-23da-4273-b504-0a2ca22c4b5a	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0891-1	71335089101	30 TABLET in 1 BOTTLE (71335-0891-1)	30 tablet	2021-04-08	0000-00-00	No	No	Current
71335-0891-2	71335089102	90 TABLET in 1 BOTTLE (71335-0891-2)	90 tablet	2018-07-02	0000-00-00	No	No	Current
71335-0891-3	71335089103	28 TABLET in 1 BOTTLE (71335-0891-3)	28 tablet	2021-12-27	0000-00-00	No	No	Current