FDA.reportPublic FDA data

NDC 80425-0220-01 - Azithromycin Dihydrate

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
80425-0220
Requested NDC
80425-0220-01
Package NDCs from labels
80425-0220-1, 80425-0220-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azithromycin Dihydrate - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0220-1Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED13
80425-0220-1Azithromycin Dihydrate3 in 1 BLISTER PACKTABLET, FILM COATED33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0220AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]3Current NDC, Legacy NDC, 2 package rows20250102_f1755cf3-bf7f-be40-e053-2a95a90a8536.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0220-1EA - Each80425-022022a79a88-900b-42f3-b136-01e841c3680c12023-06-06

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 1 of 7 · 126 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.94e17ae5-0871-67a0-e053-2995a90ae0ae2026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
azithromycinAZITHROMYCINREMEDYREPACK INC.da399401-1ee6-422a-be46-0bba6b264b2f2026-09-08Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINAurobindo Pharma Limited3c902990-b870-4725-b9fe-76b8be633e1c2026-09-03Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
azithromycinAZITHROMYCINMajor Pharmaceuticals814abe38-da4a-48af-bf4b-2ce04a5aabd12026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
azithromycinAZITHROMYCINREMEDYREPACK INC.bf061799-cdef-40f8-b1ce-bc5eb609f8c32026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINAurobindo Pharma Limited795c13cd-e9ca-481b-9fa9-2890bdf9dac82026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.0d5129e4-8b94-4a4d-baa9-be0d6b32d7142026-08-31Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.f0cfda1a-910f-4764-8658-263037df5ea82026-08-28Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
azithromycinAZITHROMYCINLupin Pharmaceuticals, Inc.01649d79-4677-4577-a3e4-e054f3f9fc3b2026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S
azithromycinAZITHROMYCINLupin Pharmaceuticals, Inc.c9990a1d-5238-403e-9221-72a9314d7b5e2026-08-20Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINZydus Pharmaceuticals USA Inc.99e5bd22-a721-4e2e-a46c-d61a53c25c3d2026-08-14Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINREMEDYREPACK INC.614cc2a4-3fc7-455d-9e8a-212c496f0fbf2026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.c7ed6985-1d1d-48af-9df8-64b12821789e2026-08-04Warnings, Adverse reactionsExact identifier
application number: ANDA208249
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINSandoz Inc34b70c23-92a6-460f-8dbb-15a0e6b9d3a92026-07-30Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.a9cdb5ae-2aeb-c598-e053-2a95a90a80622026-07-30Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATENuCare Pharmaceuticals,Inc.21c67de0-3a4e-caab-e063-6394a90ae3cd2026-07-30Warnings, Adverse reactionsExact identifier
application number: ANDA208249
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINSandoz Incec619299-e0ef-44dd-acdb-8c53bbfc5b8a2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions882f71b1-b153-4856-b4a7-1a29ae9cf2472026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.0c926669-62b2-4ad3-8289-173c5818a9c12026-07-29Warnings, Adverse reactionsExact identifier
application number: ANDA208249
rxcui: 248656
unii: 5FD1131I7S
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Incdb52b91e-79f7-4cc1-9564-f2eee8e31c452026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S

Reported adverse events (FAERS/openFDA)#

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