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Erythromycin Lactobionate

Erythromycin Lactobionate for Injection, USP For Intravenous Use Only Vials

Approved
Approval ID

171b8b28-9da6-4bc6-85ea-f27fde5d5f10

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 9, 2023

Manufacturers
FDA

Nexus Pharmaceuticals Inc.

DUNS: 620714787

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 Code14789-116
Application NumberANDA215290
Product Classification
M
Marketing Category
C73584
G
Generic Name
Erythromycin Lactobionate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateMarch 9, 2023
FDA Product Classification

INGREDIENTS (2)

Erythromycin LactobionateActive
Quantity: 500 mg in 10 mL
Code: 33H58I7GLQ
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 3/9/2023

DESCRIPTION

Erythromycin is produced by a strain of Streptomyces erythraeus and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids.

Erythromycin lactobionate for injection, USP is a soluble salt of erythromycin suitable for intravenous administration. The lactobionic acid content is 244 mg per vial. Lactobionic acid and/or erythromycin are used to adjust the pH during the manufacture of the product. When reconstituted as directed, each mL contains 50 mg of erythromycin activity. The pH of the reconstituted solution is 6.5 -7.5.

Erythromycin lactobionate is chemically known as erythromycin mono (4-0-β-Dgalactopyranosyl-D-gluconate) (salt). The structural formula is:

Structural Formula

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Erythromycin Lactobionate - FDA Drug Approval Details