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
5ed68b5a-4093-49f1-871b-7b0da5f7be2d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azithromycin
PRODUCT DETAILS
NDC Product Code50090-6267
Application NumberANDA211147
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 2, 2022
Generic NameAzithromycin
INGREDIENTS (7)
AZITHROMYCIN DIHYDRATEActive
Quantity: 200 mg in 5 mL
Code: 5FD1131I7S
Classification: ACTIM
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT