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 3 of 12 · 229 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzithromycinAZITHROMYCINBryant Ranch Prepackb5d79719-b1dc-469f-a19c-f8ba615138f02026-05-14Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
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
azithromycinAZITHROMYCINCoupler LLC510024c9-6658-e08f-e063-6294a90a07932026-05-04Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.d9b66736-3f1a-4d6d-bdc4-274f5adfb40c2026-04-14Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
azithromycinAZITHROMYCINCardinal Health 107, LLCea128124-8712-4998-be46-47d43ef127d42026-04-10Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPrecision Dose, Inc.3962bc34-8236-4ac1-8ffd-2edbd430c3eb2026-04-08Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINBryant Ranch Prepacka81212ef-76b6-4bd7-8706-3d2b05ee34f92026-03-30Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions24c07398-84ad-48e2-9625-e9073c28fb732026-03-24Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions77c5e4c6-6d16-40fe-bf36-cb441348f39b2026-03-24Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINAvKAREdc633b7d-5154-7e43-e053-2a95a90ad2a62026-03-17Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATEDIRECT RXa6426d5f-5518-3c69-e053-2995a90af50f2026-03-17Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINDIRECT RXa5b4092d-ab72-f5d1-e053-2995a90ac5822026-03-17Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.003307c5-3f73-4a5d-a704-bfdea3c656e82026-03-16Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.4eec460d-5ba8-4614-8700-219a9b4fc3852026-03-16Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINPreferred Pharmaceuticals Inc.a1c96531-bbd2-4dc5-8eeb-3f0276cd09562026-03-11Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEA-S Medication Solutionsde5b0c2b-9a7d-46e9-8169-4100442efa9b2026-03-03Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
azithromycinAZITHROMYCINRising Pharma Holdings, Inc.5199689f-8881-7757-e063-6394a90ae2eb2026-02-26Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.23de6b8e-7622-4ba6-89f7-37bd151687e22026-02-26WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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