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 2 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZITHROMYCINAZITHROMYCINA-S Medication Solutions405ab07f-7d1d-4552-ad3b-2a03be8e99492026-02-17Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AZITHROMYCINAZITHROMYCINEpic Pharma, LLC59c4b783-4ff7-4269-969b-58a10e12b12b2026-02-04Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AzithromycinAZITHROMYCINSportpharm LLC5f9e13f5-69ee-4220-90d9-31fa8660d8802026-02-03Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
AzithromycinAZITHROMYCINAvKARE16da30a2-d11c-7e8c-e063-6294a90a62e32026-01-13Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
Sterile Cord Blood Collection Unit (MSC128D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions251fd4cb-4aa4-4473-9f89-968da856eb772025-12-18WarningsExact identifier
unii: 2968PHW8QP
Sterile Cord Blood Collection Unit (MSC127D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTIONMaco Productions75a008b2-9666-4bfa-ab18-6d09b43b22152025-12-18WarningsExact identifier
unii: 2968PHW8QP
Pall Sterile Cord Blood Collection UnitSTERILE CORD BLOOD COLLECTION UNITGlobal Life Sciences Solutions USA LLCaa9340b7-cc63-e17d-e053-2a95a90ad4d92025-12-18WarningsExact identifier
unii: 2968PHW8QP
STERILE CORD BLOOD COLLECTION UNIT (MSC123D)ANTICOAGULANT CITRATE PHOSPHATE DEXTROSEMaco Productionse3b456ec-4578-485f-a696-8a343505f30b2025-12-16WarningsExact identifier
unii: 2968PHW8QP
PaxLyteLEUCOVORIN, FOLIC ACID, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL 5-PHOSPHATE, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE (THIAMINE PYROPHOSPHATE), MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE AND BETAINE CAPSULEJaymac Pharmaceuticalsf520b130-61b3-443e-aaf6-91e094e7a3342025-12-08Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 2968PHW8QP
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 2968PHW8QP
AZITHROMYCINAZITHROMYCINPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS714f6f55-278a-4fcf-8d4e-2ad9b43623a32025-11-20Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
Earthmed Soothe Chewable OrangeCITRIC ACIDEarthmed LLC439543fe-ceb9-4c5c-e063-6294a90a9b702025-11-14WarningsExact identifier
unii: 2968PHW8QP
AQUACETIC-30CLEANING SOLUTION FOR HEMODIALYSIS MACHINESAqua Medica, S.A. de C.V.040775ab-41bd-cd36-e063-6394a90a08aa2025-11-10WarningsExact identifier
unii: 2968PHW8QP
CITRACID-50DESINFECTANT SOLUTION FOR HEMODIALYSIS MACHINEAqua Medica, S.A. de C.V.040713e7-67cd-8eb0-e063-6394a90aa2a92025-11-10WarningsExact identifier
unii: 2968PHW8QP
AZITHROMYCINAZITHROMYCINNuCare Pharmaceuticals, Inc.3f7c7421-411d-c04e-e063-6394a90a4aa02025-09-23Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
unii: 2968PHW8QP
AzithromycinAZITHROMYCIN MONOHYDRATESagent Pharmaceuticalscefbce3f-3e6c-4659-abd7-3ec3e82277372025-07-28Warnings, Adverse reactionsExact identifier
application number: ANDA065501
rxcui: 1668238
unii: JTE4MNN1MD

Reported adverse events (FAERS/openFDA)#

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