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FDA labels

Search the openFDA drug-label export by label identifier, NDC, application, RxCUI, UNII, product name, or manufacturer.

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report.

Label matches#

FDA label search results page 2 of 2 · 49 matching rows.

Label, Generic name, Manufacturer table
LabelGeneric nameManufacturerSPL set IDEffective dateSafety fieldsMatch
montelukast sodiumMONTELUKAST SODIUMCamber Pharmaceuticals, Inc.23964723-2df8-4d0a-a53d-8538469672f12021-06-18Boxed warning, Warnings, Adverse reactionsName/manufacturer search
MONTELUKAST SODIUMMONTELUKAST SODIUMProficient Rx LP901385e5-7384-4c28-a36a-7dd84c36f5fd2021-01-01Warnings, Adverse reactionsName/manufacturer search
MONTELUKAST SODIUMMONTELUKAST SODIUMProficient Rx LP54014b67-3163-4c8f-b93a-229cd231ca6b2021-01-01Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMProficient Rx LP8a724790-e1fb-4935-bb28-ce99455be5ef2019-11-01Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKAST SODIUMProficient Rx LP0f2dbf17-bce0-4e09-8c22-898d93be80da2019-11-01Warnings, Adverse reactionsName/manufacturer search
MONTELUKASTMONTELUKAST SODIUMA-S Medication Solutionsda9821f1-536a-416b-9594-210bde0cefaf2025-12-11Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Montelukast SodiumMONTELUKASTAmneal Pharmaceuticals LLCbcd49102-a21c-4628-a322-6cdd934e7f092025-04-18Boxed warning, Warnings, Adverse reactionsName/manufacturer search
MONTELUKAST SODIUMMONTELUKASTProficient Rx LPcab84c43-96a3-4868-88da-3126685edf002019-10-01Warnings, Adverse reactionsName/manufacturer search
SINGULAIRMONTELUKAST SODIUMOrganon LLC482dcc92-b47f-4ea6-854a-f5ac2aea78422025-04-30Boxed warning, Warnings, Adverse reactionsName/manufacturer search