Erythromycin Ethylsuccinate
Approved
Approval ID
6d8c343b-30d9-4cdb-8f55-2a20983a71c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 29, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-0018
Application NumberANDA061904
Product Classification
M
Marketing Category
C73584
G
Generic Name
erythromycin ethylsuccinate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 29, 2010
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ERYTHROMYCIN ETHYLSUCCINATEActive
Quantity: 400 mg in 1 1
Code: 1014KSJ86F
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT