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 6 of 12 · 229 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
azithromycinAZITHROMYCINLannett Company, Inc.a2b0c06b-e93d-f5aa-e053-2995a90ac9aa2025-05-13Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AzithromycinAZITHROMYCINA-S Medication Solutions47a8fd64-5a3d-490e-8ca8-5e6721c830cf2025-05-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDKesin Pharma Corporation3140f8fe-0644-7561-e063-6394a90a2c282025-04-21Adverse reactionsExact identifier
unii: XF417D3PSL
azithromycin dihydrateAZITHROMYCIN DIHYDRATESlate Run Pharmaceuticals, LLC33d4ac05-b564-440c-971d-b78590dd2c322025-04-17Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Bio Co Enzyme PhaseACONITICUM ACIDUM, CIS-, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ADRENALINUM, , ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBICUM ACIDUM, BARIUM OXALSUCCINICUM, BETA VULGARIS, CERIUM OXALICUM, CITRICUM ACIDUM, CYSTEINUM, FUMARICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM PHOSPHORICUM, NADIDUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PANTOTHENIC ACID, PROTEUS (MORGANI), PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM,Deseret Biologicals, Inc.6edee6eb-0ec9-4d2a-9dc9-dc2a6503a6db2025-04-08WarningsExact identifier
unii: XF417D3PSL
azithromycinAZITHROMYCINProficient Rx LP25bc2e78-9d0d-41c6-a55e-a267d44579672025-04-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEPD-Rx Pharmaceuticals, Inc.e9800bbe-e8bf-4689-a8a5-dc23b5d2ee562025-03-26Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATETAGI Pharma, Inc.9f0501bf-d1c4-46a5-b253-3b9e61015e822025-03-07Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATETAGI Pharma, Inc.41e2163b-af61-4323-8b9c-2d44fc122fd92025-03-05Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
87b9089f-c9cd-41c9-9358-29f6e4014af68d24bacb-feff-4c6a-b8df-625e1435387a2025-02-10Warnings, Adverse reactionsExact identifier
spl id: 87b9089f-c9cd-41c9-9358-29f6e4014af6
spl set id: 8d24bacb-feff-4c6a-b8df-625e1435387a
AzithromycinAZITHROMYCIN MONOHYDRATEAthenex Pharmaceutical Division, LLC.610a34ea-6aa7-4b94-a85a-ff16ca537d032025-01-28Warnings, Adverse reactionsExact identifier
rxcui: 1668238
AzithromycinAZITHROMYCIN MONOHYDRATEAthenex Pharmaceutical Division, LLC.324330c5-20fe-4b22-adf2-14a6e91e71ef2025-01-28Warnings, Adverse reactionsExact identifier
rxcui: 1668238
azithromycin dihydrateAZITHROMYCIN DIHYDRATECoupler LLC2cc93e72-95ce-965b-e063-6394a90a89172025-01-28Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATECoupler LLC2cc99fae-a72c-8893-e063-6394a90aa3ef2025-01-28Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
AZITHROMYCINAZITHROMYCINDirect_Rx8e6e11fb-eb9e-28ec-e053-2a95a90aa1a32025-01-22Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAvPAKfe070e2e-3e72-fb84-e053-6294a90afd882025-01-09Adverse reactionsExact identifier
unii: XF417D3PSL
AzithromycinAZITHROMYCINZydus Lifesciences Limited0b63649d-558c-4250-90ee-af6e1e5c6d2c2025-01-09Exact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEProficient Rx LPa8e106cb-7245-45a5-9aad-bd624b1e011d2025-01-01Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx Pharmacy of Tennessee, LLCf1752913-85ac-01fa-e053-2995a90a2bd82024-12-31Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S
Azithromycin DihydrateAZITHROMYCIN DIHYDRATEAdvanced Rx of Tennessee, LLCf1755cf3-bf7f-be40-e053-2a95a90a85362024-12-31Warnings, Adverse reactionsExact identifier
unii: 5FD1131I7S

Reported adverse events (FAERS/openFDA)#

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