FDA.reportPublic FDA data

NDC 76420-403 - 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
76420-403
Package NDCs from labels
76420-403-06
Manufacturer
ASCLEMED USA INC.
Effective date
2025-06-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azithromycin - ASCLEMED USA INC.ASCLEMED USA INC.2025-06-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-403-06Azithromycin1 in 1 CARTONTABLET, FILM COATED11
76420-403-06Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED61

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 2 of 112 · 2,230 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azithromycin monohydrateAZITHROMYCIN MONOHYDRATEGland Pharma Limited55051e03-b6dc-4bc6-87c1-e4fb84b61fa32026-08-12Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
AzithromycinAZITHROMYCINREMEDYREPACK INC.614cc2a4-3fc7-455d-9e8a-212c496f0fbf2026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 248656
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.c7ed6985-1d1d-48af-9df8-64b12821789e2026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 248656
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.a9cdb5ae-2aeb-c598-e053-2a95a90a80622026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 308460
Azithromycin DihydrateAZITHROMYCIN DIHYDRATENuCare Pharmaceuticals,Inc.21c67de0-3a4e-caab-e063-6394a90ae3cd2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINSandoz Incec619299-e0ef-44dd-acdb-8c53bbfc5b8a2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 308460
rxcui: 248656
rxcui: 749783
AzithromycinAZITHROMYCINA-S Medication Solutions882f71b1-b153-4856-b4a7-1a29ae9cf2472026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.0c926669-62b2-4ad3-8289-173c5818a9c12026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 248656
AzithromycinAZITHROMYCINEugia US LLC7b81436e-d14a-4353-a22d-253f45e2e5762026-07-27Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Incdb52b91e-79f7-4cc1-9564-f2eee8e31c452026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 308460
rxcui: 248656
rxcui: 749783
AzithromycinAZITHROMYCINREMEDYREPACK INC.5f144e92-c9eb-420a-9bb8-4265a9f20a982026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 308460
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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