Erythromycin Lactobionate
Approved
Approval ID
e69b3024-f4bd-456e-8c74-2f9bc33739c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2021
Manufacturers
FDA
Exela Pharma Sciences, LLC
DUNS: 831274399
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ERYTHROMYCIN LACTOBIONATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51754-7000
Application NumberANDA211086
Product Classification
M
Marketing Category
C73584
G
Generic Name
ERYTHROMYCIN LACTOBIONATE
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 15, 2021
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ERYTHROMYCIN LACTOBIONATEActive
Quantity: 500 mg in 10 mL
Code: 33H58I7GLQ
Classification: ACTIM