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 2 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Montelukast SodiumMONTELUKAST SODIUMPD-Rx Pharmaceuticals, Inc.6ffff72c-8784-477b-8722-5434a19881a02025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma USA Inc.67070e4e-f755-46b3-b900-fcc1993a05462025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Montelukast SodiumMONTELUKAST SODIUMMajor Pharmaceuticalsa4dc63cf-8145-42f4-9437-93b414d2aed42025-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MontelukastMONTELUKASTSandoz Inc6d69e73a-76cb-4ece-9cf9-e9adb4f523b42025-06-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MontelukastMONTELUKASTNuCare Pharmaceuticals, Inc.365e1c5c-01b2-bf4e-e063-6394a90a0e432025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
SINGULAIRMONTELUKAST SODIUMOrganon LLC482dcc92-b47f-4ea6-854a-f5ac2aea78422025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Montelukast SodiumMONTELUKASTAmneal Pharmaceuticals LLCbcd49102-a21c-4628-a322-6cdd934e7f092025-04-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MONTELUKAST SODIUMMONTELUKAST SODIUMCamber Pharmaceuticals, Inc.97a682c2-7e00-4d07-a5ac-4436c977f8422025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MontelukastMONTELUKASTQuallent Pharmaceuticals Health LLC5d71088b-b0fa-4bf0-a6e7-6163bd9e0dd42025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MONTELUKAST SODIUMMONTELUKAST SODIUMDirect_Rxf3bdf2a3-d661-5128-e053-2995a90a46612025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
montelukast sodiumMONTELUKAST SODIUMNuCare Pharmaceuticals,Inc.a7c11cbe-0834-27a5-e053-2995a90ac43f2024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
Montelukast SodiumMONTELUKAST SODIUMAmerican Health Packagingfb1b2e4e-a840-447b-b943-ad0b6acc32b52024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
montelukast sodiumMONTELUKAST SODIUMBryant Ranch Prepack3ff4100f-11e3-4d6a-ab88-83bd605a18182024-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
MontelukastMONTELUKASTBryant Ranch Prepack6b26218d-52a6-4109-90e4-412a17d14fcf2024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
MONTELUKAST SODIUMMONTELUKAST SODIUMRising Pharma Holdings, Inc.75723c5a-3c9e-468a-bc65-57b4c755889a2024-07-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL

Reported adverse events (FAERS/openFDA)#

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