FDA.reportPublic FDA data

NDC 70860-100-41 - 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
70860-100
Requested NDC
70860-100-41
Package NDCs from labels
70860-100-41, 70860-100-10
Manufacturer
Athenex Pharmaceutical Division, LLC.
Effective date
2025-01-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azithromycin - Athenex Pharmaceutical Division, LLC.Athenex Pharmaceutical Division, LLC.2025-01-28HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-100-102024-03-01C16284748780-11030e365-2075-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AZITHROMYCIN FOR INJECTION safely and effectively. See full prescribing information for AZITHROMYCIN FOR INJECTION. AZITHROMYCIN for injection, for intravenous use Initial U.S. Approval: 1991
70860-100-102024-01-30C16284748780-11030e365-2075-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AZITHROMYCIN FOR INJECTION safely and effectively. See full prescribing information for AZITHROMYCIN FOR INJECTION. AZITHROMYCIN for injection, for intravenous use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70860-100-10Azithromycin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1013
70860-100-41Azithromycin5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,513

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-100AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]13Current NDC, Legacy NDC, 2 package rows20250130_324330c5-20fe-4b22-adf2-14a6e91e71ef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-100-10EA - Each70860-100dd577842-230a-4df3-b415-4f4e6fb3a75912017-03-06
70860-100-41EA - Each70860-100de9ede2f-242e-4e2e-84f9-478c00ff560b12019-04-11

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 4 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sal de Uvas PicotCITRIC ACID MONOHYDRATE AND SODIUM BICARBONATERB Health Mexico, S.A. de C.V.151b9bc9-1a6e-4401-ae58-4b4210ab45052024-11-15WarningsExact identifier
unii: 2968PHW8QP
Lungex IIGINKGO BILOBA, COLON (SUIS), LUNG (SUIS), PANCREAS SUIS, GERMANIUM SESQUIOXIDE, CUPRUM METALLICUM, MANGANUM METALLICUM, STANNUM METALLICUM, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALIC ACID, PYRUVIC ACID, SUCCINICUM ACIDUM, NAPHTHOQUINONE, ARSENICUM METALLICUM, CALCAREA CARBONICA, ACONITICUM ACIDUM, CIS, NATRUM OXALACETICUM, PHOSPHORUSEnergique, Inc.ddf7fc46-95b7-44b4-b7ca-96a066a3fa2b2024-10-28WarningsExact identifier
unii: 2968PHW8QP
AzithromycinAZITHROMYCIN MONOHYDRATEFresenius Kabi USA, LLCb69917c0-95d5-4b29-b0e3-07054a4fd79f2024-10-11Warnings, Adverse reactionsExact identifier
rxcui: 1668238
unii: JTE4MNN1MD
AzithromycinAZITHROMYCIN MONOHYDRATEFresenius Kabi USA, LLC9ad099d5-5c57-4855-98a4-e03fb4629dbf2024-10-11Warnings, Adverse reactionsExact identifier
rxcui: 1668238
unii: JTE4MNN1MD
AzithromycinAZITHROMYCIN MONOHYDRATESagent Pharmaceuticals6497fb5e-82d8-4411-b994-7ee01333ffd72024-09-19Warnings, Adverse reactionsExact identifier
application number: ANDA065501
rxcui: 1668238
unii: JTE4MNN1MD
AZASITEAZITHROMYCIN MONOHYDRATEThea Pharma Inc.0c5d6f5e-18ea-436f-8c62-bbaf66effe3d2024-07-25Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.549cdd0a-da79-23b8-e054-00144ff8d46c2024-07-17Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.90a506cd-aae7-a622-e053-2a95a90ad3522024-06-19Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.82454fb2-e524-ecb8-e053-2991aa0a6e7c2024-06-14Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals,Inc.8389c336-25eb-a96f-e053-2a91aa0a0dd82024-06-14Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell RX, LLC525136c9-7758-437b-b57b-94b9057868252024-05-31Adverse reactionsExact identifier
unii: 2968PHW8QP
AzithromycinAZITHROMYCINChartwell RX, LLC2c9de2e9-c20c-4660-a272-a22019f9fb022024-04-09Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AzithromycinAZITHROMYCINProficient Rx LP44134421-cb0b-4e85-a3c8-d58bdb476fad2024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AzithromycinAZITHROMYCINSTATE HEALTH SERVICES, TEXAS DEPARTMENT OF2b821631-0df2-0fb2-e054-00144ff8d46c2024-02-29Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
OracitCITRIC ACID AND SODIUM CITRATECMP Pharma, Inc.bc26abed-8e6e-475d-8ab3-abf7d03770032023-12-07Adverse reactionsExact identifier
unii: 2968PHW8QP
PhexxiLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.173ff411-7227-47b0-94dc-844e1ebaf14e2023-11-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
AzithromycinAZITHROMYCINAsclemed USA, Inc.9c44af6d-8a9a-cb4c-e053-2a95a90afdac2023-09-01Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AzithromycinAZITHROMYCINTeva Pharmaceuticals USA, Inc.f6a52c0b-45db-422e-8c22-e867a11b44392023-03-01Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AzithromycinAZITHROMYCIN DIHYDRATESlate Run Pharmaceuticals8acce3c1-f4be-4968-a71f-3ffd9fbaa4a42022-12-01Warnings, Adverse reactionsExact identifier
rxcui: 1668238
AZITHROMYCINAZITHROMYCINProficient Rx LPe1172805-0930-4fb9-8a2f-e0d6a04306302022-11-01Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD

Reported adverse events (FAERS/openFDA)#

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