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 6 of 10 · 187 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINZydus Lifesciences Limited0b63649d-558c-4250-90ee-af6e1e5c6d2c2025-01-09Exact identifier
application number: ANDA211147
rxcui: 141963
rxcui: 308459
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LPa8e106cb-7245-45a5-9aad-bd624b1e011d2025-01-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx Pharmacy of Tennessee, LLCf1752913-85ac-01fa-e053-2995a90a2bd82024-12-31Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx of Tennessee, LLCf1755cf3-bf7f-be40-e053-2a95a90a85362024-12-31Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATENuCare Pharmaceuticals Inc.258dd3c5-dce9-7483-e063-6294a90a40432024-12-26Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.adfee6ce-05b0-4955-bf5f-9612b8db4c782024-12-26WarningsExact identifier
unii: C151H8M554
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEQuality Care Products, LLC2065c4ba-e3f5-41a2-b3d5-205dab6469242024-12-19Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
FocusADENOSINUM CYCLOPHOSPHORICUM, ADRENALINUM, AETHUSA CYNAPIUM, ALPHA-KETOGLUTARICUM ACIDUM, AMBRA GRISEA, BARYTA CARBONICA, CANDIDA ALBICANS, CARBONEUM SULPHURATUM, CEREBRUM SUIS, GINKGO BILOBA, HELLEBORUS NIGER, HYPOTHALAMUS SUIS, HYOSCYAMUS NIGER, IODIUM, PHOSPHORUS, SACCHARUM OFFICINALE, SARCOLACTICUM ACID, SILICEA, TARENTULA HISPANA, VERATRUM ALBUMDeseret Biologicals, Inc.e014e6b6-a07a-4170-b9af-f477da71597d2024-11-13WarningsExact identifier
unii: C151H8M554
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LPbb97a057-2537-41ae-b50c-a80605039c302024-11-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
LactistatARSENICUM ALBUM, CALCAREA CARBONICA, COCCULUS INDICUS, GRAPHITES, HYDROFLUORICUM ACIDUM, LACHESIS MUTUS, LACTICUM ACIDUM, RHUS TOX, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SACCHARUM OFFICINALEEnergique, Inc.8dcc4a3a-9f21-4a77-ae42-b2c8283a076a2024-10-28WarningsExact identifier
unii: C151H8M554
Grain and Seed AntigensBAMBOO, BARLEY, CORN, COTTON SEED, FLAX SEED (LINUM USITATISSIMUM), MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SAFFLOWER, SESAME, SORGHUM, SOY BEAN, SUGARCANE, SUNFLOWER (HELIANTHUS ANNUUS), WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUREnergique, Inc.a028eaea-76ef-45db-80e1-d7b4a0655d5e2024-10-25WarningsExact identifier
unii: C151H8M554
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsfcf098d5-dfd5-4a0d-81f7-6afa1a203a272024-10-15Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsb4c05e22-4a54-4948-abf8-8a479d465d302024-10-15Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINAsclemed USA, Inc.22a4d2b3-daea-4d96-891f-4b98236294562024-10-04Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINProficient Rx LP90605f94-93e1-43d1-8be7-830e816ac84f2024-10-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINProficient Rx LP38942011-f86b-4e42-a4ca-05a70d9dd3d92024-10-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Gut Brain SpectrumABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, HELIUM, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUMEnergique, Inc.cb1566a4-92d4-4f1a-9211-f0c538a83c272024-09-27WarningsExact identifier
unii: C151H8M554
PMS ReliefAGNUS CASTUS, AURUM SULPHURATUM, CANDIDA ALBICANS, CIMICIFUGA RACEMOSA, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, FOLLICULINUM, HYPOTHALAMUS SUIS, KALI CARBONICUM, LAC CANINUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), SACCHARUM OFFICINALE, STANNUM METALLICUM, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Deseret Biologicals, Inc.f03d8463-0a6d-4577-8fba-9cba246d3d452024-09-23WarningsExact identifier
unii: C151H8M554
FocusGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, IODIUM, PHOSPHORUS, SARCOLACTICUM ACID, SACCHARUM OFFICINALE, ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, SILICEA, ADRENALINUM, AMBRA GRISEA, CARBONEUM SULPHURATUM, TARENTULA HISPANA, AETHUSA CYNAPIUM, BARYTA CARBONICA, HELLEBORUS NIGER, VERATRUM ALBUM, CANDIDA ALBICANS, HYOSCYAMUS NIGERDeseret Biologicals, Inc.e77857b8-be67-4041-8c8d-9772f17c6d062024-09-11WarningsExact identifier
unii: C151H8M554
PMS ReliefAGNUS CASTUS, CIMICIFUGA RACEMOSA, KALI CARBONICUM, LYCOPODIUM CLAVATUM, SACCHARUM OFFICINALE, THYROIDINUM (BOVINE), HYPOTHALAMUS SUIS, ARISTOLOCHIA CLEMATITIS, FOLLICULINUM, AURUM SULPHURATUM, CANDIDA ALBICANS, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, LAC CANINUM, LACHESIS MUTUS, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), STANNUM METALLICUMDeseret Biologicals, Inc.ca073beb-330d-406c-9bf5-196a89f3ab582024-09-11WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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