FDA.reportPublic FDA data

NDC 70710-1457-01 - 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
70710-1457
Requested NDC
70710-1457-01
Package NDCs from labels
70710-1457-1, 70710-1457-01
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited
Effective date
2026-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azithromycin - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Global FZE | Zydus Lifesciences Limited2026-08-14HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2024-02-26HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2021-02-17HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2020-03-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1457-1Azithromycin1 in 1 CARTONPOWDER, FOR SUSPENSION17
70710-1457-1Azithromycin15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION157

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1457AZITHROMYCIN POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20250110_99e5bd22-a721-4e2e-a46c-d61a53c25c3d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1457-1ML - Milliliter70710-1457c5cdb8f1-2bad-4568-af88-2ce17ade422e12018-09-05

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 10 · 190 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.0c926669-62b2-4ad3-8289-173c5818a9c12026-07-29Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Incdb52b91e-79f7-4cc1-9564-f2eee8e31c452026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 141963
rxcui: 308459
unii: 5FD1131I7S
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
unii: 5FD1131I7S
AzithromycinAZITHROMYCINBryant Ranch Prepack2a8010dc-700f-45d3-94ca-ebe4a51acc1b2026-07-20Warnings, Adverse reactionsExact identifier
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
AZITHROMYCINAZITHROMYCINA-S Medication Solutions76093152-e2d7-4fe1-8568-1f0fec1747c22026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 141963
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEBryant Ranch Prepack7d78cd8e-0c63-46d6-b018-939fcbbe42a62026-06-24Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.661ff7a6-6394-493d-a307-a1f607e5d1172026-06-16Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEREMEDYREPACK INC.7711e846-0bb3-486c-8511-f445e264cd982026-06-12Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINBryant Ranch Prepackb5d79719-b1dc-469f-a19c-f8ba615138f02026-05-14Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
azithromycinAZITHROMYCINCoupler LLC510024c9-6658-e08f-e063-6294a90a07932026-05-04Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
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
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: C151H8M554
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: C151H8M554
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.3962bc34-8236-4ac1-8ffd-2edbd430c3eb2026-04-08Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S

Reported adverse events (FAERS/openFDA)#

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