Home NDC 72789-310-30 Fenofibrate
Product NDC 72789-310
Requested package NDC 72789-310-30
11-digit product format 727890310
Labeler code 72789
Product ID 72789-310_4bbc4809-ec1c-375d-e063-6394a90a1cfc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fenofibrate
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA201748
Marketing category ANDA
Marketing start 2015-03-02
Substance FENOFIBRATE
Active strength 130 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 43 .
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 A201748-001 FENOFIBRATE (MICRONIZED) FENOFIBRATE 43MG CAPSULE / ORAL 2014-10-31 A201748-002 FENOFIBRATE (MICRONIZED) FENOFIBRATE 130MG CAPSULE / ORAL 2014-10-31
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 · 86 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 A201748-001 FENOFIBRATE (MICRONIZED) 43MG CAPSULE / ORAL 2014-10-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 A201748-002 FENOFIBRATE (MICRONIZED) 130MG CAPSULE / ORAL 2014-10-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A201748-001 FENOFIBRATE (MICRONIZED) 43MG CAPSULE / ORAL 2014-10-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201748-002 FENOFIBRATE (MICRONIZED) 130MG CAPSULE / ORAL 2014-10-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201748-001 FENOFIBRATE (MICRONIZED) 43MG CAPSULE / ORAL 2014-10-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201748-002 FENOFIBRATE (MICRONIZED) 130MG CAPSULE / ORAL 2014-10-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201748-001 FENOFIBRATE (MICRONIZED) 43MG CAPSULE / ORAL 2014-10-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201748-002 FENOFIBRATE (MICRONIZED) 130MG CAPSULE / ORAL 2014-10-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201748-001 FENOFIBRATE 43MG CAPSULE / ORAL AB 2014-10-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A201748-002 FENOFIBRATE 130MG CAPSULE / ORAL AB 2014-10-31 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Fenofibrate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FENOFIBRATE 130 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 483425 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 72789-310-30 Fenofibrate 30 in 1 BOTTLE, PLASTIC CAPSULE 30 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-310 FENOFIBRATE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 13 Current NDC, 1 package rows 20250221_2f5cee5c-ec55-4e9b-9d54-e7f2f052130e.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72789-310-30 72789031030 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-310-30) 30 capsule 2022-03-15 No No Current