Home NDC 27437-109 ANTARA
Product NDC 27437-109
11-digit product format 274370109
Labeler code 27437
Product ID 27437-109_945dde7a-9442-4421-8bc8-7f7d6de013f8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name FENOFIBRATE
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application NDA021695
Marketing category NDA
Marketing start 2009-09-25
Substance FENOFIBRATE
Active strength 43 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 · 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N021695-004 ANTARA (MICRONIZED) FENOFIBRATE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 N021695-005 ANTARA (MICRONIZED) FENOFIBRATE 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18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.
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.
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 43 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 483425 Internal RxNorm lookup 483427 Internal RxNorm lookup 578797 Internal RxNorm lookup 578799 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 27437-109-01 ANTARA 100 in 1 BOTTLE CAPSULE 100 17 27437-109-06 ANTARA 30 in 1 BOTTLE CAPSULE 30 17
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27437-109 ANTARA (FENOFIBRATE) CAPSULE [LUPIN PHARMACEUTICALS, INC.] 15 Current NDC, Legacy NDC, 2 package rows 20240821_24790a18-0291-4b88-a724-acac43b616ce.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 27437-109-01 27437010901 100 CAPSULE in 1 BOTTLE (27437-109-01) 100 capsule 2009-09-25 0000-00-00 No No Current 27437-109-06 27437010906 30 CAPSULE in 1 BOTTLE (27437-109-06) 30 capsule 2009-09-25 0000-00-00 No No Current