FDA.reportPublic FDA data

NDC 80425-0219-01 - 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
80425-0219
Requested NDC
80425-0219-01
Package NDCs from labels
80425-0219-1, 80425-0219-01
Manufacturer
Advanced Rx Pharmacy 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 - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0219-1Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED63
80425-0219-1Azithromycin1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0219AZITHROMYCIN TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, Legacy NDC, 2 package rows20250102_f175496a-4ad3-ce0d-e053-2a95a90a6613.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0219-1EA - Each80425-02193a756988-9a67-4f12-8caa-8cd4eccca03312023-06-06

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 5 · 85 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
azithromycinAZITHROMYCINREMEDYREPACK INC.da399401-1ee6-422a-be46-0bba6b264b2f2026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 308460
AzithromycinAZITHROMYCINAurobindo Pharma Limited795c13cd-e9ca-481b-9fa9-2890bdf9dac82026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 308460
rxcui: 749783
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.f0cfda1a-910f-4764-8658-263037df5ea82026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 308460
rxcui: 749783
azithromycinAZITHROMYCINLupin Pharmaceuticals, Inc.01649d79-4677-4577-a3e4-e054f3f9fc3b2026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 308460
rxcui: 749783
Azithromycin monohydrateAZITHROMYCIN MONOHYDRATEGland Pharma Limited55051e03-b6dc-4bc6-87c1-e4fb84b61fa32026-08-12Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.a9cdb5ae-2aeb-c598-e053-2a95a90a80622026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 308460
AzithromycinAZITHROMYCINSandoz Incec619299-e0ef-44dd-acdb-8c53bbfc5b8a2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 308460
rxcui: 749783
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: 308460
rxcui: 749783
AzithromycinAZITHROMYCINBryant Ranch Prepack6caeda98-7020-413a-9461-04f476dad4ba2026-07-20Warnings, Adverse reactionsExact identifier
rxcui: 308460
AzithromycinAZITHROMYCINREMEDYREPACK INC.333ffe63-aaeb-4dff-b595-1c11209189a62026-07-01Warnings, Adverse reactionsExact identifier
application number: ANDA065225
rxcui: 308460
unii: JTE4MNN1MD
AZITHROMYCINAZITHROMYCINA-S Medication Solutions76093152-e2d7-4fe1-8568-1f0fec1747c22026-07-01Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AzithromycinAZITHROMYCINREMEDYREPACK INC.943b9246-7733-44b1-875c-91d2ade78ac42026-06-29Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.661ff7a6-6394-493d-a307-a1f607e5d1172026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 308460
rxcui: 749783
azithromycinAZITHROMYCINCoupler LLC510024c9-6658-e08f-e063-6294a90a07932026-05-04Warnings, Adverse reactionsExact identifier
rxcui: 308460
AzithromycinAZITHROMYCINSportpharm LLC397471e5-76e2-462c-af30-bcc54fe002662026-04-24Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.d9b66736-3f1a-4d6d-bdc4-274f5adfb40c2026-04-14Warnings, Adverse reactionsExact identifier
rxcui: 308460
rxcui: 749783
azithromycinAZITHROMYCINCardinal Health 107, LLCea128124-8712-4998-be46-47d43ef127d42026-04-10Warnings, Adverse reactionsExact identifier
rxcui: 308460
AzithromycinAZITHROMYCINAvKAREdc633b7d-5154-7e43-e053-2a95a90ad2a62026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 308460
AZITHROMYCINAZITHROMYCINDIRECT RXa5b4092d-ab72-f5d1-e053-2995a90ac5822026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 308460
rxcui: 749783

Reported adverse events (FAERS/openFDA)#

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