FDA.reportPublic FDA data

NDC 55111-763-07 - 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
55111-763
Requested NDC
55111-763-07
Package NDCs from labels
55111-763-07, 55111-763-03
Manufacturer
Dr.Reddy's Laboratories Limited | Dr.Reddy's Laboratories Limited-FTO3
Effective date
2019-08-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Montelukast Sodium - Dr.Reddy's Laboratories Limited | Dr.Reddy's Laboratories Limited-FTO3Dr.Reddy's Laboratories Limited | Dr.Reddy's Laboratories Limited-FTO32019-08-30HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55111-763-032025-01-30C16284748780-12cef2736-5f2d-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use MONTELUKAST SODIUM ORAL GRANULES safely and effectively. See full prescribing information for MONTELUKAST SODIUM ORAL GRANULES . MONTELUKAST SODIUM oral granules, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-763-03Montelukast Sodium30 in 1 CARTONGRANULE3015
55111-763-07Montelukast Sodium500 in 1 PACKETGRANULE50015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-763MONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]15Legacy NDC, 2 package rows20190920_3d3df874-d710-7fa4-bb21-434977518337.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-763-03EA - Each55111-763569ceb14-5889-4aeb-804d-5c1cac519e0412013-02-13
55111-763-07EA - Each55111-763ef749b31-25f5-4d9c-a7e2-3dadf931d5bf12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]12
montelukastACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]12
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82MONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]12
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]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 · 68 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
MONTELUKAST SODIUMMONTELUKAST SODIUMAjanta Pharma USA Inc.67070e4e-f755-46b3-b900-fcc1993a05462025-08-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 351246
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
rxcui: 351246
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
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
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
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

Reported adverse events (FAERS/openFDA)#

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