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 4 of 10 · 187 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPreferred Pharmaceuticals Inc.3b90572c-cc24-49f0-baaf-09022a2f9a002026-01-21Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINAiPing Pharmaceutical, Inc.d6fb42ed-7dac-4a7b-9964-d367dd47dd5c2026-01-10Warnings, Adverse reactionsExact identifier
rxcui: 141963
rxcui: 308459
unii: 5FD1131I7S
Amalgam 6003AMALGAMProfessional Complementary Health Formulas1af74f69-a23a-45a2-a20e-92bf8b0ccb222026-01-08WarningsExact identifier
unii: TTV12P4NEE
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAvPAKb635019e-7fd4-7f9e-e053-2a95a90a388c2026-01-08Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: C151H8M554
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEHealth Department, Oklahoma State4747c5d8-4831-c725-e063-6394a90a4fda2025-12-31Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATERedpharm Drug2fd1f4b5-6c32-3075-e063-6294a90a0d4b2025-12-27Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINRedpharm Drug2fd25741-f014-3999-e063-6394a90acdd02025-12-27Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINRedpharm Drug3745a0b0-7855-69eb-e063-6294a90ab6a82025-12-24Warnings, Adverse reactionsExact identifier
application number: ANDA211147
rxcui: 141963
unii: 5FD1131I7S
AzithromycinAZITHROMYCINBionpharma Inc.859bb02c-a4bc-46fa-9fc9-def1219b5dfb2025-12-04Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATERedpharm Drug44f52ce0-ad3f-7d80-e063-6294a90ad0862025-12-02Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS714f6f55-278a-4fcf-8d4e-2ad9b43623a32025-11-20Warnings, Adverse reactionsExact identifier
rxcui: 141963
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
Azithromycin DihydrateAZITHROMYCIN DIHYDRATECoupler LLC4196e616-bdd8-9e88-e063-6394a90ac81d2025-10-20Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals, Inc.3f7c7421-411d-c04e-e063-6394a90a4aa02025-09-23Warnings, Adverse reactionsExact identifier
rxcui: 141963
ZithromaxAZITHROMYCIN DIHYDRATERedpharm Drug3ddecd25-dc32-a2af-e063-6294a90a526d2025-09-03Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINZhejiang Poly Pharm. Co., Ltd.33d0a4eb-5076-65c6-e063-6394a90ac13a2025-08-22Warnings, Adverse reactionsExact identifier
rxcui: 141963
rxcui: 308459
unii: 5FD1131I7S

Reported adverse events (FAERS/openFDA)#

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