FDA.reportPublic FDA data

NDC 71335-1602-01 - 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
71335-1602
Requested NDC
71335-1602-01
Package NDCs from labels
71335-1602-1, 71335-1602-2, 71335-1602-3, 71335-1602-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-10-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
montelukast sodium - Bryant Ranch PrepackBryant Ranch Prepack2024-10-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1602-1montelukast sodium30 in 1 BOTTLETABLET, CHEWABLE305
71335-1602-2montelukast sodium90 in 1 BOTTLETABLET, CHEWABLE905
71335-1602-3montelukast sodium60 in 1 BOTTLETABLET, CHEWABLE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1602MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 3 package rows20241022_3ff4100f-11e3-4d6a-ab88-83bd605a1818.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 2 of 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
CalamineCALAMINE 8%, ZINC OXIDE 8%Farmacias De Similares TX LLC4ecd0add-11c9-cf3b-e063-6394a90adff62026-04-06WarningsExact identifier
unii: 1K09F3G675
MontelukastMONTELUKASTREMEDYREPACK INC.ecaa9b4b-5941-4af5-930c-35e9f3b2b4ba2026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: U1O3J18SFL
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
unii: 1K09F3G675
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions7ff11e37-9ea5-40b6-96f7-4caf27cab7562026-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204093
rxcui: 242438
unii: MHM278SD3E
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions1a312a28-8472-4cab-a7dd-d01cd8b2765a2026-03-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204093
rxcui: 242438
unii: MHM278SD3E
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions25b2049d-3a93-4ac3-8de6-14f5d7ce03152026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204093
rxcui: 311759
unii: MHM278SD3E
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions04b3faff-1ea1-4d2a-aa31-9d6e742e17592026-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204093
rxcui: 311759
unii: MHM278SD3E
CalamineCALAMINE, PRAMOXINE HCLAmazon.com Services LLCaceb0b10-8c90-4a06-8c47-cd1a2b4676a32026-03-03Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDChain Drug Marketing Association86ff4875-9007-4b7b-8f46-16cbd475d4bb2026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLChain Drug Marketing Association6c848b98-f01c-40f2-a9aa-2af76cb370c82026-02-27Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Levico PrunusLEVICO PRUNUSUriel Pharmacy Inc.63db9374-8ee2-48cf-8799-454c958698082026-02-27WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDFamily Dollar Stores, Inc1a03331e-3676-451c-be22-9a547e8ae6e22026-02-24Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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