Zithromax
These highlights do not include all the information needed to use ZITHROMAX safely and effectively. See full prescribing information for ZITHROMAX. ZITHROMAX (azithromycin) 250 mg and 500 mg tablets, for oral use ZITHROMAX (azithromycin) for oral suspension Initial U.S. Approval: 1991
Approved
Approval ID
db52b91e-79f7-4cc1-9564-f2eee8e31c45
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Products 7
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
azithromycin dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-3120
Application NumberNDA050710
Product Classification
M
Marketing Category
C73594
G
Generic Name
azithromycin dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (6)
AZITHROMYCIN DIHYDRATEActive
Quantity: 200 mg in 5 mL
Code: 5FD1131I7S
Classification: ACTIM
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
azithromycin dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-3130
Application NumberNDA050710
Product Classification
M
Marketing Category
C73594
G
Generic Name
azithromycin dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (6)
AZITHROMYCIN DIHYDRATEActive
Quantity: 200 mg in 5 mL
Code: 5FD1131I7S
Classification: ACTIM
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
azithromycin dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-3140
Application NumberNDA050710
Product Classification
M
Marketing Category
C73594
G
Generic Name
azithromycin dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (6)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
AZITHROMYCIN DIHYDRATEActive
Quantity: 200 mg in 5 mL
Code: 5FD1131I7S
Classification: ACTIM
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
azithromycin dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-3060
Application NumberNDA050711
Product Classification
M
Marketing Category
C73594
G
Generic Name
azithromycin dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (11)
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AZITHROMYCIN DIHYDRATEActive
Quantity: 250 mg in 1 1
Code: 5FD1131I7S
Classification: ACTIM
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
azithromycin dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-3070
Application NumberNDA050784
Product Classification
M
Marketing Category
C73594
G
Generic Name
azithromycin dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (11)
AZITHROMYCIN DIHYDRATEActive
Quantity: 500 mg in 1 1
Code: 5FD1131I7S
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
azithromycin dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-3110
Application NumberNDA050710
Product Classification
M
Marketing Category
C73594
G
Generic Name
azithromycin dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (6)
AZITHROMYCIN DIHYDRATEActive
Quantity: 100 mg in 5 mL
Code: 5FD1131I7S
Classification: ACTIM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
azithromycin dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0069-4061
Application NumberNDA050711
Product Classification
M
Marketing Category
C73594
G
Generic Name
azithromycin dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (11)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
AZITHROMYCIN DIHYDRATEActive
Quantity: 250 mg in 1 1
Code: 5FD1131I7S
Classification: ACTIM
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT