FDA.reportPublic FDA data

NDC 50090-4458-01 - Azithromycin

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
50090-4458
Requested NDC
50090-4458-01
Package NDCs from labels
50090-4458-0, 50090-4458-1, 50090-4458-01
Manufacturer
A-S Medication Solutions
Effective date
2023-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azithromycin - A-S Medication SolutionsA-S Medication Solutions2023-02-06HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-4458-02023-02-07These highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
50090-4458-12023-02-07These highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
50090-4458-02023-01-30These highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
50090-4458-12023-01-30These highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4458-0Azithromycin30 mL in 1 BOTTLEPOWDER, FOR SUSPENSION308
50090-4458-0Azithromycin1 in 1 CARTONPOWDER, FOR SUSPENSION18
50090-4458-1Azithromycin30 in 1 BOTTLEPOWDER, FOR SUSPENSION308
50090-4458-1Azithromycin24 mL in 1 CASEPOWDER, FOR SUSPENSION248

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4458AZITHROMYCIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 4 package rows20230208_22a2bdcb-3012-42fb-ac66-d1d879100940.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4458-0ML - Milliliter50090-445800cd2ffe-86cc-47ae-aae0-47faac0aa07f12024-03-12

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 7 of 10 · 187 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LPedecf20d-c681-418b-9c47-02fb32d2b3c02024-09-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
azithromycin dihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx of Tennessee, LLC20ae108a-00c5-a984-e063-6394a90aaaae2024-08-27Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutionsf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b2024-07-22Warnings, Adverse reactionsExact identifier
rxcui: 141963
rxcui: 308459
unii: 5FD1131I7S
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.b0138503-ddc4-2e1c-e053-2995a90a0d2d2024-07-17Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.b43d23c7-1a2e-ce93-e053-2995a90a65a42024-07-17Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.549cdd0a-da79-23b8-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsExact identifier
rxcui: 308459
azithromycin dihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx of Tennessee, LLC1cec44fa-9597-3e58-e063-6394a90ae3262024-07-12Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.90a506cd-aae7-a622-e053-2a95a90ad3522024-06-19Warnings, Adverse reactionsExact identifier
rxcui: 308459
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.9270e676-3382-6483-e053-2a95a90a556e2024-06-19Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.8e7184e1-3c3c-cd87-e053-2a95a90a6eb62024-06-18Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.82454fb2-e524-ecb8-e053-2991aa0a6e7c2024-06-14Warnings, Adverse reactionsExact identifier
rxcui: 141963
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.826f9c07-8eb9-a128-e053-2991aa0ad6542024-06-14Warnings, Adverse reactionsExact identifier
application number: ANDA211147
rxcui: 141963
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.8389c336-25eb-a96f-e053-2a91aa0a0dd82024-06-14Warnings, Adverse reactionsExact identifier
rxcui: 141963
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.896cce83-23ac-f4ed-e053-2a95a90ad1072024-06-14Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutions1c84a68b-3eaa-4dab-b5e5-e195c7652e672024-06-14Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions4278e306-bc26-4282-93ce-f1405e0b5d4a2024-06-12Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: C151H8M554
IntimateNATRUM CARBONICUM, SACCHARUM OFFICINALE, LITHIUM CARBONICUM, PLACENTA TOTALIS SUIS, LAC CANINUM, ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, GERMANIUM METALLICUM, HELLEBORUS NIGER, MAGNESIA OXYDATA, RHUS GLABRA, STRAMONIUM, THUJA OCCIDENTALIS, DNA (HUMAN), OXYTOCIN, HYDROGEN, NEON, LAC MATERNA HUMANUMDeseret Biologicals, Inc.ca0447c1-606e-443a-b789-7d65143fec282024-05-13WarningsExact identifier
unii: C151H8M554
GlyregACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCADeseret Biologicals, Inc28e670ca-ed35-4256-af20-74c25dc180992024-04-23WarningsExact identifier
unii: C151H8M554
AzithromycinAZITHROMYCINChartwell RX, LLC2c9de2e9-c20c-4660-a272-a22019f9fb022024-04-09Warnings, Adverse reactionsExact identifier
rxcui: 141963
rxcui: 308459

Reported adverse events (FAERS/openFDA)#

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