Fenofibric acid

Product NDC: 68180-128
11-digit product format: 681800128
Labeler code: 68180
Product ID: 68180-128_574221bf-1643-4dd4-8ac6-29f387ce5eaf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fenofibric acid
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA200750
Marketing category: ANDA
Marketing start: 2013-12-04
Substance: CHOLINE FENOFIBRATE
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68180-128	68180-128-09	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A200750-001	FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB		2013-12-04
A200750-002	FENOFIBRIC ACID	CHOLINE FENOFIBRATE	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB		2013-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200750-001	AB
A200750-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200750-001	FENOFIBRIC ACID	EQ 45MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200750-002	FENOFIBRIC ACID	EQ 135MG FENOFIBRIC ACID	CAPSULE, DELAYED RELEASE / ORAL	AB	2013-12-04	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A200750-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200750-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200750-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200750-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200750-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200750-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200750-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200750-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200750-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200750-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200750-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200750-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200750-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200750-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200750-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200750-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200750-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200750-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200750-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200750-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200750-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200750-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200750-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200750-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200750-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200750-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200750-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200750-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200750-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200750-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200750-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200750-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200750-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200750-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200750-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200750-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200750-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200750-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200750-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200750-002	AB	1	`bb7c543d1eb4…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fenofibric acid
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHOLINE FENOFIBRATE	45 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4BMH7IZT98	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
b9a3f97c-9e31-4a5f-822f-c9d45e394493	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
68180-128-01	2023-12-05	These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules for oral use Initial U.S. Approval: 2008
68180-128-02	2023-12-05	These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules for oral use Initial U.S. Approval: 2008
68180-128-09	2023-12-05	These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules for oral use Initial U.S. Approval: 2008
68180-128-01	2023-01-30	These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules for oral use Initial U.S. Approval: 2008
68180-128-02	2023-01-30	These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules for oral use Initial U.S. Approval: 2008
68180-128-09	2023-01-30	These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules for oral use Initial U.S. Approval: 2008
68180-128-01	2020-03-11	These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules for oral use Initial U.S. Approval: 2008
68180-128-02	2020-03-11	These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules for oral use Initial U.S. Approval: 2008
68180-128-09	2020-03-11	These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules for oral use Initial U.S. Approval: 2008
68180-128-01	2020-01-31	These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules for oral use Initial U.S. Approval: 2008
68180-128-02	2020-01-31	These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules for oral use Initial U.S. Approval: 2008
68180-128-09	2020-01-31	These highlights do not include all the information needed to use FENOFIBRIC ACID DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for FENOFIBRIC ACID DELAYED-RELEASE CAPSULES. FENOFIBRIC ACID delayed-release capsules for oral use Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68180-128-01	Fenofibric acid	100 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	100	12
68180-128-02	Fenofibric acid	500 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	500	12
68180-128-09	Fenofibric acid	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-128-09	EA - Each	68180-128	f5b53faf-0111-40a3-a3f1-4dcae78b0fa8	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHOLINE FENOFIBRATE	ACTIVE INGREDIENT	4BMH7IZT98	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
DIBUTYL SEBACATE	INACTIVE INGREDIENT	4W5IH7FLNY	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-128	FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [LUPIN PHARMACEUTICALS, INC.]	12	Current NDC, Legacy NDC, 3 package rows	20231216_b9a3f97c-9e31-4a5f-822f-c9d45e394493.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fenofibric acid	FENOFIBRIC ACID	Lupin Pharmaceuticals, Inc.	b9a3f97c-9e31-4a5f-822f-c9d45e394493	2023-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200750 application number: ANDA200750 ndc (product): 68180-128

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4BMH7IZT98	CHOLINE FENOFIBRATE	856676-23-8	CHOLINE FENOFIBRATE
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	b9a3f97c-9e31-4a5f-822f-c9d45e394493	12
828379	fenofibric acid 45 MG Delayed Release Oral Capsule	PSN	b9a3f97c-9e31-4a5f-822f-c9d45e394493	12
828373	fenofibric acid 135 MG Delayed Release Oral Capsule	SCD	b9a3f97c-9e31-4a5f-822f-c9d45e394493	12
828379	fenofibric acid 45 MG Delayed Release Oral Capsule	SCD	b9a3f97c-9e31-4a5f-822f-c9d45e394493	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-128-01	68180012801	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-128-01)	2013-12-04	0000-00-00	No	No	Current
68180-128-02	68180012802	500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-128-02)	2013-12-04	0000-00-00	No	No	Current
68180-128-09	68180012809	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68180-128-09)	2013-12-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fenofibric acid	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2023-12-08	HUMAN PRESCRIPTION DRUG LABEL	12