FDA.reportPublic FDA data

NDC 50090-5366-01 - 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
50090-5366
Requested NDC
50090-5366-01
Package NDCs from labels
50090-5366-1, 50090-5366-0, 50090-5366-01
Manufacturer
A-S Medication Solutions
Effective date
2026-03-24
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 Solutions2026-03-24Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-5366-02023-02-07These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
50090-5366-12023-02-07These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
50090-5366-02023-01-30These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
50090-5366-12023-01-30These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5366-0Azithromycin5 in 1 BOTTLETABLET, FILM COATED511
50090-5366-1Azithromycin1 in 1 BOTTLETABLET, FILM COATED111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5366AZITHROMYCIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20230919_77c5e4c6-6d16-40fe-bf36-cb441348f39b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5366-0EA - Each50090-53668041c255-9248-4d0e-be71-6cd0135cccc812023-10-16
50090-5366-1EA - Each50090-5366b06a415d-e193-4e34-af75-c1551c33021812023-10-16

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 102 of 107 · 2,136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: 15FIX9V2JP
AzithromycinAZITHROMYCINAsclemed USA, Inc.9c44af6d-8a9a-cb4c-e053-2a95a90afdac2023-09-01Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 308460
rxcui: 248656
rxcui: 749783
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 15FIX9V2JP
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 15FIX9V2JP
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 368GB5141J
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 368GB5141J
Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium ShadeSPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADEAutumn Harpfd6807e1-c8c0-b361-e053-6294a90aea0c2023-06-05WarningsExact identifier
unii: 15FIX9V2JP
Thinksport Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC77b63c0b-353b-4f5f-95c7-6f7eeab814712023-05-30WarningsExact identifier
unii: 15FIX9V2JP
Think Kids Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC25c59820-a08d-4abe-87ae-a787ac8b2ac22023-05-30WarningsExact identifier
unii: 15FIX9V2JP
AzithromycinAZITHROMYCINA-S Medication Solutionsaf720986-48a9-48b5-bdd7-370f6a2f92e12023-04-24Warnings, Adverse reactionsExact identifier
rxcui: 308460
unii: 5FD1131I7S
Mineral Sunscreen SPF 50ZINC OXIDE TITANIUM DIOXIDETopiderm, Inc.3a637542-0f79-47ae-815d-84d0036c737a2023-02-13WarningsExact identifier
unii: 15FIX9V2JP
AzithromycinAZITHROMYCINA-S Medication Solutions22a2bdcb-3012-42fb-ac66-d1d8791009402023-02-06Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutions0f36ba37-a742-41c1-ad2d-b890a1d49c552023-02-06Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINAlembic Pharmaceuticals Limited5dca5a11-3c02-4a51-a35d-f91f37b8e00c2023-01-27Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Josie Maran Argan Daily Moisturizer SPF47ZINC OXIDE, TITANIUM DIOXIDEAutumn Harp, Inc.027821e6-db7d-4c03-956a-00313488ebc72023-01-14Boxed warning, WarningsExact identifier
unii: 15FIX9V2JP
AzithromycinAZITHROMYCINAlembic Pharmaceuticals Limitedd5c95c30-564f-4b67-ac6d-9179cdfaa5a82023-01-13Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 368GB5141J
AzithromycinAZITHROMYCINAlembic Pharmaceuticals Limiteddeea1a56-84ed-4ce4-9d11-03271510c0a12023-01-12Warnings, Adverse reactionsExact identifier
rxcui: 308460
rxcui: 749783
unii: 5FD1131I7S
AzithromycinAZITHROMYCIN DIHYDRATESlate Run Pharmaceuticals8acce3c1-f4be-4968-a71f-3ffd9fbaa4a42022-12-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINProficient Rx LP34e6364a-ac3d-434e-a90c-cb13ebcf79832022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S

Reported adverse events (FAERS/openFDA)#

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