Azithromycin
These highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively.See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspensionInitial U.S. Approval: 1991
Approved
Approval ID
3209b147-11ce-4eeb-8427-5f8e6fb2c83d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azithromycin
PRODUCT DETAILS
NDC Product Code0093-2026
Application NumberANDA065246
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 26, 2022
Generic NameAzithromycin
INGREDIENTS (8)
AZITHROMYCIN MONOHYDRATEActive
Quantity: 200 mg in 5 mL
Code: JTE4MNN1MD
Classification: ACTIM
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
Azithromycin
PRODUCT DETAILS
NDC Product Code0093-2027
Application NumberANDA065246
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 26, 2022
Generic NameAzithromycin
INGREDIENTS (8)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMERInactive
Code: 905HNO1SIH
Classification: IACT
AZITHROMYCIN MONOHYDRATEActive
Quantity: 100 mg in 5 mL
Code: JTE4MNN1MD
Classification: ACTIM
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT