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 3 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhexxLACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATEEvofem, Inc.14b01a15-9b47-4be3-bb2e-a2010eab429e2025-05-02Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
TricitratesTRICITRATESChartwell RX, LLC2a80ea6b-6334-4c33-a35e-a5cb2939fbcb2025-04-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell RX, LLC978a5a9d-f0ca-4308-a84b-3b132263bbb82025-04-09Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer Heartburn Relief Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCdc1641f8-54c2-0d86-e053-2995a90a1dce2025-03-11WarningsExact identifier
unii: 2968PHW8QP
AzithromycinAZITHROMYCIN MONOHYDRATEAthenex Pharmaceutical Division, LLC.610a34ea-6aa7-4b94-a85a-ff16ca537d032025-01-28Warnings, Adverse reactionsExact identifier
application number: ANDA065501
rxcui: 1668238
unii: JTE4MNN1MD
AzithromycinAZITHROMYCIN MONOHYDRATEAthenex Pharmaceutical Division, LLC.324330c5-20fe-4b22-adf2-14a6e91e71ef2025-01-28Warnings, Adverse reactionsExact identifier
application number: ANDA065501
ndc (package): 70860-100-41
ndc (package): 70860-100-10
ndc (product): 70860-100
ndc11 (package): 70860010041
rxcui: 1668238
spl id: 2cc930e3-dd57-6e2f-e063-6294a90a3111
spl set id: 324330c5-20fe-4b22-adf2-14a6e91e71ef
unii: JTE4MNN1MD
Anticoagulant Citrate Dextrose A ACD-AANTICOAGULANT CITRATE DEXTROSE A ACD-AArteriocyte Medical Systems, Inc.b850deac-161f-4bb0-ac7f-bceac2a230c02025-01-23Exact identifier
unii: 2968PHW8QP
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 2968PHW8QP
AZITHROMYCINAZITHROMYCINDirectRxd564d91e-3039-c120-e053-2995a90ae6db2025-01-21Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a27a71-b7b2-12aa-e063-6294a90a312f2025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a7720f-1e74-7578-e063-6394a90a5eae2025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78060-7f0d-c4bd-e063-6294a90ae1522025-01-15WarningsExact identifier
unii: 2968PHW8QP
Soothe ChewableCITRIC ACIDCarolina Cannabis Creations LLC04a78a5c-e3b5-f362-e063-6394a90a08072025-01-15WarningsExact identifier
unii: 2968PHW8QP
D-99ATROPA BELLADONNA, NITROGLYCERIN, LACTIC ACID, UNSPECIFIED FORM, SCROPHULARIA NODOSA, ALOE, RADIUM BROMIDE, POTASSIUM IODIDE, SUS SCROFA BONE MARROW, ZINC, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.dd9c0226-35ea-445a-a570-1ec35551f68d2025-01-13WarningsExact identifier
unii: 2968PHW8QP
D-97ALUMINUM OXIDE, SILVER, SILVER NITRATE, ARSENIC TRIOXIDE, MERCURIUS SOLUBILIS, CALOMEL, MERCURIC IODIDE, LEAD, LEAD IODIDE, CHELIDONIUM MAJUS, ZINC, SOLIDAGO VIRGAUREA FLOWERING TOP, AND CITRIC ACID MONOHYDRATEDNA Labs, Inc.b2079abb-786c-4f92-8d49-5606c77f7d722025-01-13WarningsExact identifier
unii: 2968PHW8QP
AzithromycinAZITHROMYCINAdvanced Rx Pharmacy of Tennessee, LLCf175496a-4ad3-ce0d-e053-2a95a90a66132024-12-31Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharmace42122f-8087-471f-b0a3-5524bdbd45262024-11-19Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
TRICITRATESPOTASSIUM CITRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATEPAI Holdings, LLC dba PAI Pharma2ecb42a2-82f1-456b-8f1e-02c2d0a7b5ad2024-11-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP

Reported adverse events (FAERS/openFDA)#

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