FDA.reportPublic FDA data

NDC 0069-0400-01 - Zithromax

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
0069-0400
Requested NDC
0069-0400-01
Package NDCs from labels
0069-0400-01, 0069-0400-10
Manufacturer
Pfizer Laboratories Div Pfizer Inc | Pharmacia & Upjohn Company LLC | Pfizer Ireland Pharmaceuticals Unlimited Company
Effective date
2026-09-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZithromaxPfizer Laboratories Div Pfizer Inc | Pharmacia & Upjohn Company LLC | Pfizer Ireland Pharmaceuticals Unlimited Company2026-09-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0400-01Zithromax5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,525
0069-0400-10Zithromax10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1025

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0400ZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]25Current NDC, Legacy NDC, 2 package rows20250212_8d24bacb-feff-4c6a-b8df-625e1435387a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0400-01EA - Each0069-0400d7c08308-f15a-4aba-9d7c-7c2716a206c112014-04-03
0069-0400-10EA - Each0069-0400e0653e4e-6e09-4e11-a661-10801d9d44eb12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZITHROMYCIN DIHYDRATEACTIVE INGREDIENT5FD1131I7SZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]7
AZITHROMYCIN ANHYDROUSACTIVE MOIETYJ2KLZ20U1MZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]7
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IZITHROMAX (AZITHROMYCIN DIHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]7

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 12 · 229 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TERUFLEX Blood Anticoagulant Citrate Phosphate Dextrose Adenine (CPDA-1) for Collection of 450mL of BloodANHYDROUS CITRIC ACID, TRISODIUM CITRATE DIHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, DEXTROSE MONOHYDRATE, AND ADENINETerumo Corporation02015040-9b71-4dbe-8f8d-e0d0951e8f932024-09-19WarningsExact identifier
unii: XF417D3PSL
AzithromycinAZITHROMYCIN MONOHYDRATESagent Pharmaceuticals6497fb5e-82d8-4411-b994-7ee01333ffd72024-09-19Warnings, Adverse reactionsExact identifier
rxcui: 1668238
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LPedecf20d-c681-418b-9c47-02fb32d2b3c02024-09-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
azithromycin dihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx of Tennessee, LLC20ae108a-00c5-a984-e063-6394a90aaaae2024-08-27Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
unii: XF417D3PSL
AzithromycinAZITHROMYCINA-S Medication Solutionsf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b2024-07-22Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.b0138503-ddc4-2e1c-e053-2995a90a0d2d2024-07-17Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.b43d23c7-1a2e-ce93-e053-2995a90a65a42024-07-17Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAmerican Health Packaging58fa9952-c8ab-4ebb-a073-15cc45f4832a2024-07-16Adverse reactionsExact identifier
unii: XF417D3PSL
azithromycin dihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx of Tennessee, LLC1cec44fa-9597-3e58-e063-6394a90ae3262024-07-12Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.9270e676-3382-6483-e053-2a95a90a556e2024-06-19Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.8e7184e1-3c3c-cd87-e053-2a95a90a6eb62024-06-18Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.826f9c07-8eb9-a128-e053-2991aa0ad6542024-06-14Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINNuCare Pharmaceuticals,Inc.896cce83-23ac-f4ed-e053-2a95a90ad1072024-06-14Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutions1c84a68b-3eaa-4dab-b5e5-e195c7652e672024-06-14Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions4278e306-bc26-4282-93ce-f1405e0b5d4a2024-06-12Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
REFL HSADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)Deseret Biologicals, Inc.83249aee-f58b-442d-9187-6de0cf070e4d2024-04-29WarningsExact identifier
unii: XF417D3PSL
GlucoregASCORBICUM ACIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SARCOLACTICUM ACIDUM, THIAMINUM HYDROCHLORICUM, DHEA (DEHYDROEPIANDROSTERONE), ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, ACETALDEHYDE, INSULINUM (SUIS), INSULINUM (HUMAN), HEPAR SUIS, PANCREAS SUIS, PHLORIDZINUM, ALLOXANUM, BERBERIS VULGARIS, CARCINOSIN, LYCOPODIUM CLAVATUM, MOMORDICA BALSAMINA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM,Deseret Biologicals, Inc.c77d0682-a000-4783-a91c-d4e205c347742024-04-29WarningsExact identifier
unii: XF417D3PSL
A01 CELLULAR RECHARGEACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREAApex Energetics Inc.b932ebd3-afea-6a95-e053-2995a90a27352024-01-08WarningsExact identifier
unii: XF417D3PSL
A12 DTX-KIDNEYAPIS MELLIFICA, BERBERIS VULGARIS, BETULA PUBESCENS BARK, BETULA VERRUCOSA LEAF, BOS TAURUS KIDNEY, BOS TAURUS URINARY BLADDER, CITRICUM ACIDUM, CITRUS LIMONUM, FAGUS SYLVESTRIS FLOWER BUD, NATRUM MURIATICUM, PETROSELINUM SATIVUM, QUERCUS ROBUR FLOWER BUD, SINUSITISINUM, SOLIDAGO VIRGAUREAApex Energetics Inc.bf52e26f-aa27-87ca-e053-2995a90a23e72024-01-08WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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