ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN ETHYLSUCCINATE TABLETS, USP
Approved
Approval ID
23a0564e-dca9-41bc-b2c7-0461169f65f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2023
Manufacturers
FDA
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
DUNS: 117505635
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Erythromycin Ethylsuccinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-110
Application NumberANDA061904
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin Ethylsuccinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2023
FDA Product Classification
INGREDIENTS (7)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ERYTHROMYCIN ETHYLSUCCINATEActive
Quantity: 400 mg in 1 1
Code: 1014KSJ86F
Classification: ACTIM
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT