Ery-Ped
ERY-PED (ERYTHROMYCIN ETHYLSUCCINATE, USP)
Approved
Approval ID
04775721-ab87-4b66-808c-d67a21032385
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2023
Manufacturers
FDA
Azurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)
DUNS: 117505635
Products 2
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 Code24338-130
Application NumberNDA050207
Product Classification
M
Marketing Category
C73594
G
Generic Name
Erythromycin Ethylsuccinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2023
FDA Product Classification
INGREDIENTS (6)
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ERYTHROMYCIN ETHYLSUCCINATEActive
Quantity: 400 mg in 5 mL
Code: 1014KSJ86F
Classification: ACTIM
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
Erythromycin Ethylsuccinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24338-132
Application NumberNDA050207
Product Classification
M
Marketing Category
C73594
G
Generic Name
Erythromycin Ethylsuccinate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 16, 2023
FDA Product Classification
INGREDIENTS (6)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
CARAMELInactive
Code: T9D99G2B1R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ERYTHROMYCIN ETHYLSUCCINATEActive
Quantity: 200 mg in 5 mL
Code: 1014KSJ86F
Classification: ACTIM