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 5 of 10 · 187 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: C151H8M554
AzithromycinAZITHROMYCINAlembic Pharmaceuticals Inc.4314da8a-40e5-4aba-a32b-57b4166ade302025-06-30Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINAmerican Health Packaging6169e56c-10fb-448d-ab0f-14e54fcf28172025-06-12Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsdf9b39b7-d42d-4c4b-b492-9fd228978dec2025-06-12Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: C151H8M554
azithromycinAZITHROMYCINLannett Company, Inc.a2b0c06b-e93d-f5aa-e053-2995a90ac9aa2025-05-13Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
ShameADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALISDeseret Biologicals, Inc.090e4a23-3e1b-4b0c-a0cc-0172b05f7b642025-05-07WarningsExact identifier
unii: C151H8M554
AzithromycinAZITHROMYCINA-S Medication Solutions47a8fd64-5a3d-490e-8ca8-5e6721c830cf2025-05-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
azithromycin dihydrateAZITHROMYCIN DIHYDRATESlate Run Pharmaceuticals, LLC33d4ac05-b564-440c-971d-b78590dd2c322025-04-17Warnings, Adverse reactionsExact identifier
rxcui: 141963
rxcui: 308459
unii: 5FD1131I7S
azithromycinAZITHROMYCINProficient Rx LP25bc2e78-9d0d-41c6-a55e-a267d44579672025-04-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.e9800bbe-e8bf-4689-a8a5-dc23b5d2ee562025-03-26Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATETAGI Pharma, Inc.9f0501bf-d1c4-46a5-b253-3b9e61015e822025-03-07Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATETAGI Pharma, Inc.41e2163b-af61-4323-8b9c-2d44fc122fd92025-03-05Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
azithromycin dihydrateAZITHROMYCIN DIHYDRATECoupler LLC2cc93e72-95ce-965b-e063-6394a90a89172025-01-28Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATECoupler LLC2cc99fae-a72c-8893-e063-6394a90aa3ef2025-01-28Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINDirect_Rx8e6e11fb-eb9e-28ec-e053-2a95a90aa1a32025-01-22Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Anise PyriteANISE PYRITEUriel Pharmacy Inc.a03cdeb0-8347-40cc-8d17-5510d99575c72025-01-22WarningsExact identifier
unii: C151H8M554
AZITHROMYCINAZITHROMYCINDirectRxd564d91e-3039-c120-e053-2995a90ae6db2025-01-21Warnings, Adverse reactionsExact identifier
rxcui: 141963
A-5SUCROSEDNA Labs, Inc.8e63f697-26c1-4518-acd3-5ea72cfa27f72025-01-09WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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