FDA.reportPublic FDA data

NDC 0409-0144-21 - 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
0409-0144
Requested NDC
0409-0144-21
Package NDCs from labels
0409-0144-21, 0409-0144-11, 0409-0144-31, 0409-0144-10
Manufacturer
Hospira, Inc.
Effective date
2025-04-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azithromycin - Hospira, Inc.Hospira, Inc.2025-04-16HUMAN PRESCRIPTION DRUG LABEL
Azithromycin - Hospira, Inc.Hospira, Inc.2022-02-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0409-0144-11Azithromycin10 in 1 TRAYINJECTION, POWDER, LYOPHILIZED,1030
0409-0144-21Azithromycin1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,130

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-0144AZITHROMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]30Legacy NDC, 2 package rows20250418_d2f4907f-b952-403b-229e-cc5b8327a773.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-0144-10EA - Each0409-014445a1825c-8458-4835-88d6-312704dc5f7e12014-04-03
0409-0144-11EA - Each0409-0144644515f4-12c7-4303-8446-e287eed4ec7412012-07-24
0409-0144-21EA - Each0409-014440066a14-5c66-42e9-820b-00ff9fc0090312020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]17
AZITHROMYCIN MONOHYDRATEACTIVE INGREDIENTJTE4MNN1MDAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]15
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]15
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]15
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IAZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]15

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 1 of 8 · 143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Azithromycin monohydrateAZITHROMYCIN MONOHYDRATEGland Pharma Limited55051e03-b6dc-4bc6-87c1-e4fb84b61fa32026-08-12Warnings, Adverse reactionsExact identifier
rxcui: 1668238
unii: JTE4MNN1MD
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: XF417D3PSL
Aller-Chord AALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, BRYONIA (ALBA), CITRICUM ACIDUM, COUMARINUM, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, JUNIPERUS COMMUNIS, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, PHOSPHORUS, POTHOS FOETIDUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUR, TANACETUM VULGARE, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSEEnergetix Corporation09e89c92-112d-4320-9df5-b9f938bb90952026-08-11WarningsExact identifier
unii: XF417D3PSL
Hepatic-ToneCARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALEEnergetix Corporationd5f61f13-7e9f-4e46-8ad8-0336f36288df2026-08-11WarningsExact identifier
unii: XF417D3PSL
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: XF417D3PSL
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: XF417D3PSL
AzithromycinAZITHROMYCINEugia US LLC7b81436e-d14a-4353-a22d-253f45e2e5762026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 1668238
unii: JTE4MNN1MD
ZithromaxAZITHROMYCIN DIHYDRATEPfizer Laboratories Div Pfizer Inc3b631aa1-2d46-40bc-a614-d698301ea4f92026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 1668238
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
AzithromycinAZITHROMYCINREMEDYREPACK INC.333ffe63-aaeb-4dff-b595-1c11209189a62026-07-01Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AZITHROMYCINAZITHROMYCINA-S Medication Solutions76093152-e2d7-4fe1-8568-1f0fec1747c22026-07-01Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
AzithromycinAZITHROMYCINREMEDYREPACK INC.943b9246-7733-44b1-875c-91d2ade78ac42026-06-29Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD
a89b2215-c6f8-4930-baa5-91668e992ef4918925cc-8da9-4016-998c-c06ed4676ae42026-06-17Warnings, Adverse reactionsExact identifier
spl set id: 918925cc-8da9-4016-998c-c06ed4676ae4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: XF417D3PSL
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
9bd8fef0-89a9-48a6-b6fd-e6c2e5e8e4ecd2f4907f-b952-403b-229e-cc5b8327a7732026-05-14Warnings, Adverse reactionsExact identifier
spl set id: d2f4907f-b952-403b-229e-cc5b8327a773
Market Basket Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEDemoulas Super Markets, Inc.e15439c7-0e3c-7752-e053-2995a90a1a402026-05-11WarningsExact identifier
unii: XF417D3PSL
Meijer Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEMeijer Distribution Inc7305972b-aa0f-4daa-e053-2991aa0adfd72026-05-11WarningsExact identifier
unii: XF417D3PSL
AzithromycinAZITHROMYCINSportpharm LLC397471e5-76e2-462c-af30-bcc54fe002662026-04-24Warnings, Adverse reactionsExact identifier
unii: JTE4MNN1MD

Reported adverse events (FAERS/openFDA)#

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