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 9 of 10 · 190 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.017f3bcf-0e45-d390-e063-6394a90a588e2023-07-28WarningsExact identifier
unii: C151H8M554
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.017f0210-195d-11d7-e063-6294a90aa7502023-07-27WarningsExact identifier
unii: C151H8M554
Leaky Gut FormulaALFALFA, GLYCYRRHIZA GLABRA, ASTACUS FLUVIATILIS, BERBERIS AQUIFOLIUM, LAC DEFLORATUM, NATRUM CARBONICUM, SACCHARUM OFFICINALE, ALOE, FEL TAURI, PANCREAS SUIS, PANCREATINUM, FRAGARIA VESCA, ANTIMONIUM CRUDUM, CARBO VEGETABILIS, EUPHORBIUM OFFICINARUM, LYCOPODIUM CLAVATUM, MAGNESIA CARBONICA, ZINCUM METALLICUM, COLIBACILLINUM CUM NATRUM MURIATICUM, PROTEUS (VULGARIS)Deseret Biologicals, Inc.8679e9ab-8610-47f1-be0e-66897f99881d2023-07-14WarningsExact identifier
unii: C151H8M554
Grain and Seed AntigensAMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: C151H8M554
AzithromycinAZITHROMYCINA-S Medication Solutionsaf720986-48a9-48b5-bdd7-370f6a2f92e12023-04-24Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Saccharum officinaleSUCROSEBoiron6858f374-8549-4b00-e053-2991aa0a5c3c2023-02-20Exact identifier
unii: C151H8M554
AzithromycinAZITHROMYCINA-S Medication Solutions22a2bdcb-3012-42fb-ac66-d1d8791009402023-02-06Warnings, Adverse reactionsExact identifier
application number: ANDA211147
rxcui: 141963
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutions0f36ba37-a742-41c1-ad2d-b890a1d49c552023-02-06Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINAlembic Pharmaceuticals Limited5dca5a11-3c02-4a51-a35d-f91f37b8e00c2023-01-27Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Saccharum OfficinaleSACCHARUM OFFICINALEHahnemann Laboratories, INC.f04b0ab3-af1c-ec2d-e053-2995a90a78552023-01-27Exact identifier
unii: C151H8M554
AzithromycinAZITHROMYCINAlembic Pharmaceuticals Limitedd5c95c30-564f-4b67-ac6d-9179cdfaa5a82023-01-13Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINAlembic Pharmaceuticals Limiteddeea1a56-84ed-4ce4-9d11-03271510c0a12023-01-12Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Chip CravingsCOUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUSDr. Donna Restivo DC719ef104-88f3-4db5-9c3a-1ac9a1a63c262023-01-10WarningsExact identifier
unii: C151H8M554
AzithromycinAZITHROMYCIN DIHYDRATESlate Run Pharmaceuticals8acce3c1-f4be-4968-a71f-3ffd9fbaa4a42022-12-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINProficient Rx LPe1172805-0930-4fb9-8a2f-e0d6a04306302022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 141963
AzithromycinAZITHROMYCINProficient Rx LP34e6364a-ac3d-434e-a90c-cb13ebcf79832022-11-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINProficient Rx LP33140df5-420d-469f-b6c8-121e952a5cb62022-11-01Warnings, Adverse reactionsExact identifier
application number: ANDA211147
rxcui: 141963
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINProficient Rx LPb3761d39-9b79-4908-8b05-a1c91e5999982022-11-01Warnings, Adverse reactionsExact identifier
rxcui: 141963
AzithromycinAZITHROMYCINProficient Rx LP99ca0089-14a9-446d-8807-253ad5be3efa2022-09-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINProficient Rx LPcb40f4cf-15ae-47ab-8e0a-979467fa0d9e2022-06-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S

Reported adverse events (FAERS/openFDA)#

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