Fenofibric Acid

Product NDC
46708-245
11-digit product format
467080245
Labeler code
46708
Product ID
46708-245_4f5277a1-2983-4cf9-b589-714d5fc586c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fenofibric Acid
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA208705
Marketing category
ANDA
Marketing start
2017-05-18
Substance
FENOFIBRIC ACID
Active strength
135 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 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208705-001FENOFIBRIC ACIDCHOLINE FENOFIBRATEEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12
A208705-002FENOFIBRIC ACIDCHOLINE FENOFIBRATEEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208705-001AB
A208705-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12caaa826d4ba7…
2026-08-18 06:07:402026-07A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208705-001FENOFIBRIC ACIDEQ 45MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208705-002FENOFIBRIC ACIDEQ 135MG FENOFIBRIC ACIDCAPSULE, DELAYED RELEASE / ORALAB2017-05-12bb7c543d1eb4…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208705-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208705-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208705-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208705-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208705-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208705-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208705-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208705-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208705-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208705-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208705-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208705-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208705-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208705-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208705-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208705-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208705-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208705-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208705-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208705-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208705-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208705-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208705-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208705-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208705-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208705-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208705-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208705-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208705-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208705-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208705-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208705-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208705-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208705-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208705-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208705-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208705-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208705-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208705-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A208705-002AB1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENOFIBRIC ACID135 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BGF9MN2HU1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
828373Internal RxNorm lookup
828379Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c880d43a-fa8c-4f7a-a488-419bae7cc311Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
193bb7da-5c03-8f95-9048-23ef403846b0Product name320250616
fa35fb9a-7146-716b-13c8-bc1f60030232Product name920250114
cfc78bfa-7d55-47e5-aeb7-71cd79f5ca07Product name820231212
53d5b6b7-785a-4500-9460-263c7f8424b8Product name520210105
ed9d55d4-85bd-0ee7-5b4a-b705646a3a66Product name920200708

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
46708-245-302023-02-01These 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
46708-245-902023-02-01These 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
46708-245-912023-02-01These 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
46708-245-302023-01-30These 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
46708-245-902023-01-30These 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
46708-245-912023-01-30These 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 NDCProductDescriptionFormQuantityStrengthSPL version
46708-245-30Fenofibric Acid30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
46708-245-90Fenofibric Acid90 in 1 BOTTLECAPSULE, DELAYED RELEASE903
46708-245-91Fenofibric Acid1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-245FENOFIBRIC ACID CAPSULE, DELAYED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 3 package rows20230202_c880d43a-fa8c-4f7a-a488-419bae7cc311.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fenofibric AcidFENOFIBRIC ACIDAlembic Pharmaceuticals Inc.8ffcb173-095a-4550-84f2-18959ad2aab82025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208705
application number: ANDA208705
Fenofibric AcidFENOFIBRIC ACIDAlembic Pharmaceuticals Limitedc880d43a-fa8c-4f7a-a488-419bae7cc3112023-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208705
application number: ANDA208705
ndc (product): 46708-245

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
828373fenofibric acid 135 MG Delayed Release Oral CapsulePSNc880d43a-fa8c-4f7a-a488-419bae7cc3113
828379fenofibric acid 45 MG Delayed Release Oral CapsulePSNc880d43a-fa8c-4f7a-a488-419bae7cc3113
828373fenofibric acid 135 MG Delayed Release Oral CapsuleSCDc880d43a-fa8c-4f7a-a488-419bae7cc3113
828379fenofibric acid 45 MG Delayed Release Oral CapsuleSCDc880d43a-fa8c-4f7a-a488-419bae7cc3113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-245-304670802453030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-30) 2017-05-180000-00-00NoNoCurrent
46708-245-904670802459090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-90) 2017-05-180000-00-00NoNoCurrent
46708-245-91467080245911000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (46708-245-91) 2017-05-180000-00-00NoNoCurrent