FDA.reportPublic FDA data

Montelukast Sodium

Manufacturer
Food and Drug Administration
Effective date
2017-12-05
Label type
INDEXING - WARNING LETTER ALERT
Version
1
Source
full-release
Hydrated at
2026-06-01 02:48:42

Label at a glance#

Productfenofibrate
Active ingredientFENOFIBRATE, MONTELUKAST SODIUM
Label structure1 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm588722.htm

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477562fenofibrate 48 MG Oral TabletPSN1
242438montelukast sodium 5 MG Chewable TabletPSN1
477562fenofibrate 48 MG Oral TabletSCD1
242438montelukast 5 MG Chewable TabletSCD1
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FENOFIBRIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
MONTELUKAST Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220
36a239c8-03fb-0083-81af-6c1afb195671Product name120140508
a0296d70-ca85-018c-84e8-cf3f630976b7Product name120140508
f2e3e9c8-a2f9-0cc3-a5a5-6dfd0279372aProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-248-83EA - Each43353-248476500b5-c002-4cb9-8a78-64bab1361a2612017-09-11
43353-252-30EA - Each43353-2522ffceed2-5c6f-4e38-b3bf-46c7e5e7e87c12017-10-13
43353-252-60EA - Each43353-252a97a40e1-bd83-4e1c-be32-07ccb0ab9c4b12017-10-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC table
Product NDC
43353-248
43353-252

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
FENOFIBRATEU202363UOSACTIB
MONTELUKAST SODIUMU1O3J18SFLACTIM

Source Document#

Source XML

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 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FenofibrateFENOFIBRATEA-S Medication Solutionsc870ea48-5dde-4a6f-9ddb-56b494bb2b552026-09-09Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.882ee82a-3c56-4173-af42-68c3aadc8aa72026-09-04Warnings, Adverse reactionsName fallback
brand name: FENOFIBRATE
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEA-S Medication Solutionsd0c7070e-b3bb-4b5b-8a62-4e3136b5accc2026-08-28Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEREMEDYREPACK INC.b6b5d74d-d418-4ada-8ccd-592b0f57b2ff2026-08-04Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.3b6c5ebd-a8bc-4502-8b66-f4e58914815b2026-07-30Warnings, Adverse reactionsName fallback
brand name: FENOFIBRATE
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEGolden State Medical Supply, Inc.3e611f91-e351-9558-e063-6394a90ace172026-07-27Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEMajor Pharmaceuticalsd9be3ae3-6da9-47fd-bcfd-e561b9d585ca2026-07-16Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEAmerican Health Packaging8b4488f4-bef6-408c-9fca-3e4aebceff9a2026-07-02Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEBostal LLC7eb328d0-4e6f-4b24-ae85-68c2b36575692026-06-30Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATESun Pharmaceutical Industries, Inc.2083f5d9-92f2-4c64-b996-fabbd6946ea02026-06-19Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEGolden State Medical Supply, Inc.6dd2e25c-aded-4499-e053-2991aa0a9d602026-06-16Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
fenofibrateFENOFIBRATEBryant Ranch Prepack42b1ad55-c449-4250-a666-bb36a6ff5b532026-06-11Warnings, Adverse reactionsName fallback
brand name: fenofibrate
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEA-S Medication Solutionsce403472-6c0c-4854-bb82-ba6539e1ae072026-06-10Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FENOFIBRATEFENOFIBRATEAmneal Pharmaceuticals LLC65f5dcad-5073-4347-9ec9-e7f350b134c42026-06-06Warnings, Adverse reactionsName fallback
brand name: FENOFIBRATE
generic name: FENOFIBRATE
FENOFIBRATEFENOFIBRATESt. Mary's Medical Park Pharmacyb92fb19a-d0df-426e-e053-2995a90ab3792026-06-02Warnings, Adverse reactionsName fallback
brand name: FENOFIBRATE
generic name: FENOFIBRATE
FENOFIBRATEFENOFIBRATEREMEDYREPACK INC.fa9deae7-6cbf-4559-8130-b86b23b6d0ec2026-06-01Warnings, Adverse reactionsName fallback
brand name: FENOFIBRATE
generic name: FENOFIBRATE
FenofibrateFENOFIBRATERhodes Pharmaceuticals LLC5e7b79ab-9df0-4bbf-b7a4-a44aec2035552026-06-01Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
FENOFIBRATEFENOFIBRATEBryant Ranch Prepackb11f1c74-23da-4273-b504-0a2ca22c4b5a2026-05-29Warnings, Adverse reactionsName fallback
brand name: FENOFIBRATE
generic name: FENOFIBRATE
FenofibrateFENOFIBRATEWestminster Pharmaceuticals, LLCa97ebf51-4f68-4426-9958-5c59f91b1d472026-05-22Warnings, Adverse reactionsName fallback
brand name: Fenofibrate
generic name: FENOFIBRATE
LipofenFENOFIBRATEANI Pharmaceuticals, Inc.78b789b9-854f-46b9-97f3-a48759a6ff892026-05-12Warnings, Adverse reactionsName fallback
generic name: FENOFIBRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.