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 3 of 10 · 190 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINBryant Ranch Prepacka81212ef-76b6-4bd7-8706-3d2b05ee34f92026-03-30Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions24c07398-84ad-48e2-9625-e9073c28fb732026-03-24Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions77c5e4c6-6d16-40fe-bf36-cb441348f39b2026-03-24Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINAvKAREdc633b7d-5154-7e43-e053-2a95a90ad2a62026-03-17Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATEDIRECT RXa6426d5f-5518-3c69-e053-2995a90af50f2026-03-17Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINDIRECT RXa5b4092d-ab72-f5d1-e053-2995a90ac5822026-03-17Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.003307c5-3f73-4a5d-a704-bfdea3c656e82026-03-16Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.4eec460d-5ba8-4614-8700-219a9b4fc3852026-03-16Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: C151H8M554
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: C151H8M554
AZITHROMYCINAZITHROMYCINPreferred Pharmaceuticals, Inc.9e4fbd52-43e4-4d87-a136-f4d680a8d0c12026-03-12Warnings, Adverse reactionsExact identifier
rxcui: 141963
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.ac327054-21ab-401c-a27a-48259db18f892026-03-11Warnings, Adverse reactionsExact identifier
rxcui: 308459
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.a1c96531-bbd2-4dc5-8eeb-3f0276cd09562026-03-11Warnings, Adverse reactionsExact identifier
application number: ANDA211147
rxcui: 141963
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsde5b0c2b-9a7d-46e9-8169-4100442efa9b2026-03-03Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
azithromycinAZITHROMYCINRising Pharma Holdings, Inc.5199689f-8881-7757-e063-6394a90ae2eb2026-02-26Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINA-S Medication Solutions405ab07f-7d1d-4552-ad3b-2a03be8e99492026-02-17Warnings, Adverse reactionsExact identifier
rxcui: 141963
Azithromycin DihydrateAZITHROMYCIN DIHYDRATESportpharm LLC11446677-a3dc-40cb-897d-7a9851b8c89c2026-02-06Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINEpic Pharma, LLC59c4b783-4ff7-4269-969b-58a10e12b12b2026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 141963
rxcui: 308459
AzithromycinAZITHROMYCINSportpharm LLC60ec2020-148b-4a2a-96f2-dd09c590ecbb2026-02-03Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPreferred Pharmaceuticals Inc.b3c84aea-7ba7-4aae-999c-db740a9e53df2026-01-26Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S

Reported adverse events (FAERS/openFDA)#

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