Azithromycin
These highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 250 mg and 500 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
Approved
Approval ID
f7707074-02d4-66a6-e053-6394a90a646a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 21, 2023
Manufacturers
FDA
NuCare Pharmaceuticals,Inc,
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-2963
Application NumberNDA050710
Product Classification
M
Marketing Category
C73605
G
Generic Name
Azithromycin
Product Specifications
Route of AdministrationORAL
Effective DateMarch 21, 2023
FDA Product Classification
INGREDIENTS (6)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
AZITHROMYCIN DIHYDRATEActive
Quantity: 900 mg in 22.5 mL
Code: 5FD1131I7S
Classification: ACTIM
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT