Antara

Product NDC: 27437-107
11-digit product format: 274370107
Labeler code: 27437
Product ID: 27437-107_7ca6a804-2dff-43b3-848e-7a58b31fb268
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fenofibrate
Dosage form: CAPSULE
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: NDA021695
Marketing category: NDA
Marketing start: 2013-11-01
Substance: FENOFIBRATE
Active strength: 30 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	27437-107	27437-107-06	D	Discontinued by firm		2026-08-03

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 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021695-001	ANTARA (MICRONIZED)	FENOFIBRATE	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30
N021695-002	ANTARA (MICRONIZED)	FENOFIBRATE	87MG	CAPSULE / ORAL			2004-11-30
N021695-003	ANTARA (MICRONIZED)	FENOFIBRATE	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30
N021695-004	ANTARA (MICRONIZED)	FENOFIBRATE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18
N021695-005	ANTARA (MICRONIZED)	FENOFIBRATE	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021695-001	AB
N021695-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02
N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-005	ANTARA (MICRONIZED)	90MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-005	ANTARA (MICRONIZED)	90MG	CAPSULE / ORAL		RLD	2013-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021695-001	ANTARA (MICRONIZED)	43MG	CAPSULE / ORAL	AB	RLD	2004-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021695-002	ANTARA (MICRONIZED)	87MG	CAPSULE / ORAL			2004-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021695-003	ANTARA (MICRONIZED)	130MG	CAPSULE / ORAL	AB	RLD, RS	2004-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021695-004	ANTARA (MICRONIZED)	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	2013-10-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021695-005	ANTARA (MICRONIZED)	90MG	CAPSULE / ORAL		RLD	2013-10-18	`5bbf6a4d5a75…`

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	N021695-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021695-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021695-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021695-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021695-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021695-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021695-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021695-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021695-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021695-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021695-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021695-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021695-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021695-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021695-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021695-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021695-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021695-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021695-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021695-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021695-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021695-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021695-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021695-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021695-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021695-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021695-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021695-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021695-003	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 274 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-004	8026281	2025-04-22	U-1448			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-004	8026281	2025-04-22	U-1447			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-005	8026281	2025-04-22	U-1447			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-005	8026281	2025-04-22	U-1448			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021695-004	8026281	2025-04-22	U-1448			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-004	8026281	2025-04-22	U-1447			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-005	8026281	2025-04-22	U-1447			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-005	8026281	2025-04-22	U-1448			`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-004	8026281	2025-04-22	U-1448			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-004	8026281	2025-04-22	U-1447			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-005	8026281	2025-04-22	U-1447			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-005	8026281	2025-04-22	U-1448			`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-004	8026281	2025-04-22	U-1448			`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-004	8026281	2025-04-22	U-1447			`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-005	8026281	2025-04-22	U-1447			`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-005	8026281	2025-04-22	U-1448			`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-004	8026281	2025-04-22	U-1448			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-004	8026281	2025-04-22	U-1447			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-005	8026281	2025-04-22	U-1447			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-005	8026281	2025-04-22	U-1448			`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-004	8026281	2025-04-22	U-1448			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-004	8026281	2025-04-22	U-1447			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-005	8026281	2025-04-22	U-1447			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-005	8026281	2025-04-22	U-1448			`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-005	9314447	2033-05-31	U-1447	Drug product	2016-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021695-005	9314447	2033-05-31	U-1448	Drug product	2016-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021695-004	8026281	2025-04-22	U-1448			`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021695-004	8026281	2025-04-22	U-1447			`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FENOFIBRATE	30 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1442163	Internal RxNorm lookup
1442165	Internal RxNorm lookup
1442168	Internal RxNorm lookup
1442170	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
12ebf783-64df-4ffa-9e84-f8fdf4d245d4	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
27437-107-06	Antara	30 in 1 BOTTLE	CAPSULE	30		16
27437-107-19	Antara	7 in 1 BOTTLE	CAPSULE	7		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
27437-107-06	EA - Each	27437-107	7e3bfc70-5e52-41b3-9812-85a21408be1a	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FENOFIBRATE	ACTIVE INGREDIENT	U202363UOS	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
FENOFIBRATE	ACTIVE MOIETY	U202363UOS	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
SULFUR DIOXIDE	INACTIVE INGREDIENT	0UZA3422Q4	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMA]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
27437-107	ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMACEUTICALS, INC.]	16	Current NDC, Legacy NDC, 2 package rows	20240823_12ebf783-64df-4ffa-9e84-f8fdf4d245d4.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANTARA	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	24790a18-0291-4b88-a724-acac43b616ce	2025-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021695 application number: NDA021695
Fenofibrate	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	37b25526-0bd0-4459-a4be-f3a6893506f9	2025-06-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021695 application number: NDA021695
Antara	FENOFIBRATE	Lupin Pharmaceuticals, Inc.	12ebf783-64df-4ffa-9e84-f8fdf4d245d4	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021695 application number: NDA021695 ndc (product): 27437-107

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
1442165	Antara 30 MG Oral Capsule	PSN	12ebf783-64df-4ffa-9e84-f8fdf4d245d4	16
1442170	Antara 90 MG Oral Capsule	PSN	12ebf783-64df-4ffa-9e84-f8fdf4d245d4	16
1442163	fenofibrate 30 MG Oral Capsule	PSN	12ebf783-64df-4ffa-9e84-f8fdf4d245d4	16
1442168	fenofibrate 90 MG Oral Capsule	PSN	12ebf783-64df-4ffa-9e84-f8fdf4d245d4	16
1442165	fenofibrate 30 MG Oral Capsule [Antara]	SBD	12ebf783-64df-4ffa-9e84-f8fdf4d245d4	16
1442170	fenofibrate 90 MG Oral Capsule [Antara]	SBD	12ebf783-64df-4ffa-9e84-f8fdf4d245d4	16
1442163	fenofibrate 30 MG Oral Capsule	SCD	12ebf783-64df-4ffa-9e84-f8fdf4d245d4	16
1442168	fenofibrate 90 MG Oral Capsule	SCD	12ebf783-64df-4ffa-9e84-f8fdf4d245d4	16
1442165	Antara 30 MG Oral Capsule	SY	12ebf783-64df-4ffa-9e84-f8fdf4d245d4	16
1442170	Antara 90 MG Oral Capsule	SY	12ebf783-64df-4ffa-9e84-f8fdf4d245d4	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
27437-107-06	27437010706	30 CAPSULE in 1 BOTTLE (27437-107-06)	30 capsule	2013-11-01	0000-00-00	No	No	Current
27437-107-19	27437010719	7 CAPSULE in 1 BOTTLE (27437-107-19)	7 capsule	2013-11-01	0000-00-00	No	No	Current