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 4 of 12 · 229 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
unii: XF417D3PSL
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: XF417D3PSL
Azithromycin DihydrateAZITHROMYCIN DIHYDRATESportpharm LLC11446677-a3dc-40cb-897d-7a9851b8c89c2026-02-06Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINSportpharm LLC60ec2020-148b-4a2a-96f2-dd09c590ecbb2026-02-03Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: XF417D3PSL
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPreferred Pharmaceuticals Inc.b3c84aea-7ba7-4aae-999c-db740a9e53df2026-01-26Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPreferred Pharmaceuticals Inc.3b90572c-cc24-49f0-baaf-09022a2f9a002026-01-21Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINAiPing Pharmaceutical, Inc.d6fb42ed-7dac-4a7b-9964-d367dd47dd5c2026-01-10Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAvPAKb635019e-7fd4-7f9e-e053-2a95a90a388c2026-01-08Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Cell Energy Performance Drops 2048CELL ENERGY PERFORMANCE DROPSProfessional Complementary Health Formulas8701ea61-5d5f-466b-8d2c-f808e7b4d8fe2026-01-08WarningsExact identifier
unii: XF417D3PSL
Metab 6012METABProfessional Complementary Health Formulasf3576d6f-c9ab-4370-8a32-b6c4bf6ba4fd2026-01-08WarningsExact identifier
unii: XF417D3PSL
Herbal Diuretic Liquescence 3011HERBAL DIURETIC LIQUESCENCEProfessional Complementary Health Formulas5eee7f21-a3c4-46e0-a642-a4ca635734e32026-01-08WarningsExact identifier
unii: XF417D3PSL
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEHealth Department, Oklahoma State4747c5d8-4831-c725-e063-6394a90a4fda2025-12-31Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATERedpharm Drug2fd1f4b5-6c32-3075-e063-6294a90a0d4b2025-12-27Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINRedpharm Drug2fd25741-f014-3999-e063-6394a90acdd02025-12-27Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINRedpharm Drug3745a0b0-7855-69eb-e063-6294a90ab6a82025-12-24Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
HZ-ChordBAPTISIA TINCTORIA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MEZEREUM, MORBILLINUM, NUX VOMICA, PALOONDO, PHYTOLACCA DECANDRA, SEPIA, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Energetix Corporation9685aec5-a65d-40fe-b5d7-2f13a69733bc2025-12-17WarningsExact identifier
unii: XF417D3PSL
Category VIMMUNE SYSTEM BOOSTERVitality Works, Inc,0d3dd923-336c-4ccd-a344-ec49b2e80d102025-12-17WarningsExact identifier
unii: XF417D3PSL
FCS HPEPINEPHRINE,GLUTAMICACID,MUCUNAPRURIENSSEED,NIACINAMIDE,SEROTONIN,UBIDECARENONE,CORTICOTROPIN,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATECRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inc.ba8fed68-f27f-4651-adec-0994a53758872025-12-10WarningsExact identifier
unii: XF417D3PSL
FCS CPCORTICOTROPIN,GLUTAMICACID,MUCUNAPURIENSSEED,SEROTONIN,EPINEPHRINE,NIACINAMIDE,UBIDECARENONE,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,UNSPECIFIED,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATE,CRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inccb69e9d6-62a6-4af0-8d2d-1e68b0830a202025-12-10WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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