Home DailyMed 910990bf-327b-4eb3-9f8a-5e8aed965e72 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2013-04-01
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 04:04:54
Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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N021695-004 ANTARA (MICRONIZED) FENOFIBRATE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18 N021695-005 ANTARA (MICRONIZED) FENOFIBRATE 90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE / ORAL RLD 2013-10-18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 · 215 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 2026-09-14 22:38:34 2026-08 N021695-001 ANTARA (MICRONIZED) 43MG CAPSULE / ORAL AB RLD 2004-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021695-002 ANTARA (MICRONIZED) 87MG CAPSULE / ORAL 2004-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021695-003 ANTARA (MICRONIZED) 130MG CAPSULE / ORAL AB RLD, RS 2004-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021695-001 ANTARA (MICRONIZED) 43MG CAPSULE / ORAL AB RLD 2004-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021695-002 ANTARA (MICRONIZED) 87MG CAPSULE / ORAL 2004-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021695-003 ANTARA (MICRONIZED) 130MG CAPSULE / ORAL AB RLD, RS 2004-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 278 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N021695-005 9314447 2033-05-31 U-1447 Drug product 2016-05-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021695-005 9314447 2033-05-31 U-1448 Drug product 2016-05-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021695-005 9314447 2033-05-31 U-1447 Drug product 2016-05-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021695-005 9314447 2033-05-31 U-1448 Drug product 2016-05-02 caaa826d4ba7…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…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.