azithromycin monohydrate
These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, 250 mg and 500 mg, for oral use Initial U.S. Approval: 1991
Approved
Approval ID
f6d4eb0c-f530-48da-8af0-7ed4a19619d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2020
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
azithromycin monohydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71205-119
Application NumberANDA065398
Product Classification
M
Marketing Category
C73584
G
Generic Name
azithromycin monohydrate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 1, 2020
FDA Product Classification
INGREDIENTS (10)
AZITHROMYCIN MONOHYDRATEActive
Quantity: 250 mg in 1 1
Code: JTE4MNN1MD
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT