FDA.reportPublic FDA data

NDC 50090-7920-01 - 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
50090-7920
Requested NDC
50090-7920-01
Package NDCs from labels
50090-7920-0, 50090-7920-1, 50090-7920-01
Manufacturer
A-S Medication Solutions
Effective date
2026-03-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
montelukast sodium - A-S Medication SolutionsA-S Medication Solutions2026-03-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7920-0montelukast sodium30 in 1 BOTTLETABLET, CHEWABLE301
50090-7920-1montelukast sodium90 in 1 BOTTLETABLET, CHEWABLE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7920-0EA - Each50090-79201fe7873b-6864-443a-ae70-e2a03bad083512026-04-20
50090-7920-1EA - Each50090-792099362c96-be4f-458b-bd6a-8716762e0e5112026-04-20

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 6 · 110 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
ndc (package): 50090-7920-0
ndc (package): 50090-7920-1
ndc (product): 50090-7920
ndc11 (package): 50090792001
rxcui: 311759
spl id: c678afd8-0ddd-40a3-936e-594c126a275d
spl set id: 04b3faff-1ea1-4d2a-aa31-9d6e742e1759
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
CalamineFERRIC OXIDE REDMajor Pharmaceuticalsc25be68d-834a-4959-8d47-01ec789406ba2026-02-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Aquavit 1AQUAVIT 1Uriel Pharmacy Inc.2354fcfc-05a2-444a-ace4-b3df614131572026-02-02WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINEAMERISOURCE BERGEN90d9d908-57ea-4062-ade0-8a4888939c912026-01-29Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
montelukast sodiumMONTELUKAST SODIUMPreferred Pharmaceuticals, Inc.09b0bc9e-3035-45b4-b61b-4aca708483602026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204093
rxcui: 242438
unii: MHM278SD3E
First Chakra (Root) 7301FIRST CHAKRA (ROOT)Professional Complementary Health Formulas61eb1bbe-6675-4369-b852-18975e6b08c72026-01-08WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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