Azithromycin Dihydrate
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, for oral use Initial U.S. Approval: 1991
Approved
Approval ID
f241b712-d563-45da-8708-8c291abb3b2d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2022
Manufacturers
FDA
RPK Pharmaceuticals, Inc.
DUNS: 147096275
Products 1
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 Code53002-4228
Application NumberANDA208250
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azithromycin Dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2020
FDA Product Classification
INGREDIENTS (13)
AZITHROMYCIN DIHYDRATEActive
Quantity: 250 mg in 1 1
Code: 5FD1131I7S
Classification: ACTIM
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Lecithin, soybeanInactive
Code: 1DI56QDM62
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
polyvinyl alcohol, unspecifiedInactive
Code: 532B59J990
Classification: IACT
polyethylene glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT