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 9 of 10 · 187 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.8679e9ab-8610-47f1-be0e-66897f99881d2023-07-14WarningsExact identifier
unii: C151H8M554
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: C151H8M554
AzithromycinAZITHROMYCINA-S Medication Solutionsaf720986-48a9-48b5-bdd7-370f6a2f92e12023-04-24Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Saccharum officinaleSUCROSEBoiron6858f374-8549-4b00-e053-2991aa0a5c3c2023-02-20Exact identifier
unii: C151H8M554
AzithromycinAZITHROMYCINA-S Medication Solutions22a2bdcb-3012-42fb-ac66-d1d8791009402023-02-06Warnings, Adverse reactionsExact identifier
application number: ANDA211147
ndc (package): 50090-4458-1
ndc (package): 50090-4458-0
ndc (product): 50090-4458
ndc11 (package): 50090445801
rxcui: 141963
spl id: 57c5f28a-3308-4eb6-ae6d-9e911f1f6989
spl set id: 22a2bdcb-3012-42fb-ac66-d1d879100940
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutions0f36ba37-a742-41c1-ad2d-b890a1d49c552023-02-06Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINAlembic Pharmaceuticals Limited5dca5a11-3c02-4a51-a35d-f91f37b8e00c2023-01-27Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Saccharum OfficinaleSACCHARUM OFFICINALEHahnemann Laboratories, INC.f04b0ab3-af1c-ec2d-e053-2995a90a78552023-01-27Exact identifier
unii: C151H8M554
AzithromycinAZITHROMYCINAlembic Pharmaceuticals Limitedd5c95c30-564f-4b67-ac6d-9179cdfaa5a82023-01-13Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINAlembic Pharmaceuticals Limiteddeea1a56-84ed-4ce4-9d11-03271510c0a12023-01-12Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Chip CravingsCOUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUSDr. Donna Restivo DC719ef104-88f3-4db5-9c3a-1ac9a1a63c262023-01-10WarningsExact identifier
unii: C151H8M554
AzithromycinAZITHROMYCIN DIHYDRATESlate Run Pharmaceuticals8acce3c1-f4be-4968-a71f-3ffd9fbaa4a42022-12-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINProficient Rx LPe1172805-0930-4fb9-8a2f-e0d6a04306302022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 141963
AzithromycinAZITHROMYCINProficient Rx LP34e6364a-ac3d-434e-a90c-cb13ebcf79832022-11-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINProficient Rx LP33140df5-420d-469f-b6c8-121e952a5cb62022-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA211147
rxcui: 141963
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINProficient Rx LPb3761d39-9b79-4908-8b05-a1c91e5999982022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 141963
AzithromycinAZITHROMYCINProficient Rx LP99ca0089-14a9-446d-8807-253ad5be3efa2022-09-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINProficient Rx LPcb40f4cf-15ae-47ab-8e0a-979467fa0d9e2022-06-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LP8037c6f4-4881-4740-8229-2aee56141cd02022-05-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINProficient Rx LP25f2d819-ae38-4061-a897-bbcfce3739bf2022-03-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S

Reported adverse events (FAERS/openFDA)#

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