fenofibrate

Product NDC: 27241-116
Requested package NDC: 27241-116-03
11-digit product format: 272410116
Labeler code: 27241
Product ID: 27241-116_698b59bf-d672-4ea4-8f3d-dcaee5329a39
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fenofibrate
Dosage form: TABLET
Route: ORAL
Labeler: Ajanta Pharma USA Inc.
Application: ANDA210138
Marketing category: ANDA
Marketing start: 2018-07-20
Substance: FENOFIBRATE
Active strength: 54 mg/1
Pharmacologic classes: Peroxisome Proliferator Receptor alpha Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A210138-001	FENOFIBRATE	FENOFIBRATE	54MG	TABLET / ORAL	AB		2018-07-23
A210138-002	FENOFIBRATE	FENOFIBRATE	160MG	TABLET / ORAL	AB		2018-07-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210138-001	AB
A210138-002	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	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210138-001	FENOFIBRATE	54MG	TABLET / ORAL	AB	2018-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210138-002	FENOFIBRATE	160MG	TABLET / ORAL	AB	2018-07-23	`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	A210138-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210138-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210138-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210138-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210138-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210138-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210138-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210138-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210138-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210138-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210138-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210138-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210138-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210138-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210138-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210138-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210138-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210138-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210138-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210138-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210138-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210138-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210138-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210138-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210138-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210138-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210138-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210138-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210138-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210138-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210138-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210138-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210138-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210138-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210138-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210138-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210138-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210138-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210138-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210138-002	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	54 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349287	Internal RxNorm lookup
351133	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
eb400ea7-bbd8-440b-b8be-082121621408	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	Strength	SPL version
27241-116-03	fenofibrate	90 in 1 BOTTLE	TABLET	90		15
27241-116-05	fenofibrate	500 in 1 BOTTLE	TABLET	500		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27241-116-03	EA - Each	27241-116	ca4f54ed-a048-4d05-8854-4a1f29d2ae55	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27241-116	FENOFIBRATE TABLET [AJANTA PHARMA USA INC.]	14	Current NDC, Legacy NDC, 2 package rows	20241207_eb400ea7-bbd8-440b-b8be-082121621408.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fenofibrate	FENOFIBRATE	Bryant Ranch Prepack	42b1ad55-c449-4250-a666-bb36a6ff5b53	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138
fenofibrate	FENOFIBRATE	A-S Medication Solutions	58f0d475-24dc-4f93-aa40-3882b724b70f	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138
fenofibrate	FENOFIBRATE	Ajanta Pharma USA Inc.	eb400ea7-bbd8-440b-b8be-082121621408	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138 ndc (package): 27241-116-03 ndc (product): 27241-116 ndc11 (package): 27241011603
fenofibrate	FENOFIBRATE	Quality Care Products, LLC	d1fb3b66-cac9-49cd-a9f8-c4ce960f66e7	2024-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138
fenofibrate	FENOFIBRATE	NuCare Pharmaceuticals,Inc.	8e9898d1-1fc0-b7c6-e053-2a95a90a65cd	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138
fenofibrate	FENOFIBRATE	Proficient Rx LP	b9a6866c-9dbe-4419-bcad-52ec0127821f	2022-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138
fenofibrate	FENOFIBRATE	NCS HealthCare of KY, Inc dba Vangard Labs	fafbc0be-f0ba-4dcd-8aa5-89527bae5e84	2019-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210138 application number: ANDA210138

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
349287	fenofibrate 160 MG Oral Tablet	PSN	eb400ea7-bbd8-440b-b8be-082121621408	15
351133	fenofibrate 54 MG Oral Tablet	PSN	eb400ea7-bbd8-440b-b8be-082121621408	15
349287	fenofibrate 160 MG Oral Tablet	SCD	eb400ea7-bbd8-440b-b8be-082121621408	15
351133	fenofibrate 54 MG Oral Tablet	SCD	eb400ea7-bbd8-440b-b8be-082121621408	15
351133	fenofibrate 54 MG Oral Tablet	PSN	58f0d475-24dc-4f93-aa40-3882b724b70f	9
351133	fenofibrate 54 MG Oral Tablet	SCD	58f0d475-24dc-4f93-aa40-3882b724b70f	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27241-116-03	27241011603	90 TABLET in 1 BOTTLE (27241-116-03)	90 tablet	2018-07-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
fenofibrate	A-S Medication Solutions	2026-01-09	Human Prescription Drug Label	9
fenofibrate	Ajanta Pharma USA Inc. \| Ajanta Pharma Limited, Paithan \| Ajanta Pharma Ltd., Dahej	2025-11-30	Human Prescription Drug Label	15