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 2 of 7 · 122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Inc3b631aa1-2d46-40bc-a614-d698301ea4f92026-07-24Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions3b7e16b1-9a3c-4e3a-8411-841a708afe452026-07-23Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions58308e8b-57bd-4e82-a2e8-24aac63194cd2026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINBryant Ranch Prepack2a8010dc-700f-45d3-94ca-ebe4a51acc1b2026-07-20Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINBryant Ranch Prepack6caeda98-7020-413a-9461-04f476dad4ba2026-07-20Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions3c4861f2-825e-4e3b-9907-9658a849079e2026-07-16Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINREMEDYREPACK INC.943b9246-7733-44b1-875c-91d2ade78ac42026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 248656
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEBryant Ranch Prepack7d78cd8e-0c63-46d6-b018-939fcbbe42a62026-06-24Warnings, Adverse reactionsExact identifier
application number: ANDA208249
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.661ff7a6-6394-493d-a307-a1f607e5d1172026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.7711e846-0bb3-486c-8511-f445e264cd982026-06-12Warnings, Adverse reactionsExact identifier
application number: ANDA208249
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINBryant Ranch Prepackb5d79719-b1dc-469f-a19c-f8ba615138f02026-05-14Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
azithromycinAZITHROMYCINCoupler LLC510024c9-6658-e08f-e063-6294a90a07932026-05-04Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINSportpharm LLC397471e5-76e2-462c-af30-bcc54fe002662026-04-24Warnings, Adverse reactionsExact identifier
rxcui: 248656
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.d9b66736-3f1a-4d6d-bdc4-274f5adfb40c2026-04-14Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
azithromycinAZITHROMYCINCardinal Health 107, LLCea128124-8712-4998-be46-47d43ef127d42026-04-10Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.3962bc34-8236-4ac1-8ffd-2edbd430c3eb2026-04-08Warnings, Adverse reactionsExact identifier
application number: ANDA208249
rxcui: 749780
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINBryant Ranch Prepacka81212ef-76b6-4bd7-8706-3d2b05ee34f92026-03-30Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions24c07398-84ad-48e2-9625-e9073c28fb732026-03-24Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions77c5e4c6-6d16-40fe-bf36-cb441348f39b2026-03-24Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S
AzithromycinAZITHROMYCINAvKAREdc633b7d-5154-7e43-e053-2a95a90ad2a62026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 248656
unii: 5FD1131I7S

Reported adverse events (FAERS/openFDA)#

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