FDA.reportPublic FDA data

NDC 0093-7487-19 - Montelukast Sodium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0093-7487
Requested NDC
0093-7487-19
Package NDCs from labels
0093-7487-19, 0093-7487-56
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2021-05-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Montelukast Sodium - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2021-05-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7487-19EA - Each0093-7487ee113742-0e03-42e2-ae71-dfd372fc85a812018-01-12
0093-7487-56EA - Each0093-7487360488ce-c5c5-4e72-99f3-e8eccca8c23112018-01-12

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 3 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Montelukast SodiumMONTELUKAST SODIUMNuCare Pharmaceuticals,Inc.566a8fd7-fc00-2297-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MontelukastMONTELUKASTNuCare Pharmaceuticals,Inc.56429f04-97b6-06a9-e054-00144ff88e882024-07-17Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Montelukast SodiumMONTELUKAST SODIUMNuCare Pharmaceuticals,Inc.549f1d1a-81f5-29f5-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J
montelukast sodiumMONTELUKAST SODIUMBryant Ranch Prepack9beb1510-f3af-4269-a9d0-e2bd41ac369b2024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Montelukast SodiumMONTELUKAST SODIUMAurobindo Pharma Limitedba42b0a9-83f1-4283-a853-f99cdd0761b92024-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 368GB5141J
Montelukast SodiumMONTELUKAST SODIUMWestminster Pharmaceuticals, LLCc0daaaf3-6717-4a01-e053-2995a90af2d82024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MontelukastMONTELUKASTA-S Medication Solutions6741830f-5d90-4066-bc3b-065059bc150d2023-11-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Montelukast SodiumMONTELUKAST SODIUMBryant Ranch Prepack4ba27278-6249-4546-9331-b19302cbf2db2023-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Montelukast SodiumMONTELUKAST SODIUMProficient Rx LP07d5fbea-b183-41c9-a20f-30da1f44ab1b2023-10-01Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 368GB5141J
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 368GB5141J
Montelukast SodiumMONTELUKAST SODIUMLannett Company, Inc.c43d1edb-c162-4317-9a89-d84e4eff55122023-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Montelukast SodiumMONTELUKAST SODIUMAurobindo Pharma Limited9a3bfc59-0ca6-4433-abf5-41659bfe0a8f2023-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Montelukast SodiumMONTELUKAST SODIUMProficient Rx LP461f2aaa-e091-478e-97c1-27a089db8cdc2023-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MontelukastMONTELUKASTMacleods Pharmaceuticals Limitede0c5b856-3f70-4ca6-9763-a90673bb82fb2023-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL

Reported adverse events (FAERS/openFDA)#

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