Erythromycin Lactobionate injection is erythromycin lactobionate for injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Piramal Critical Care Inc., this product is identified by NDC 66794-251 and is authorized under FDA application ANDA216761.
Identification & Billing
NDC Package Code
66794-251-41
Package Description
10 VIAL in 1 CARTON / 500 INJECTION, POWDER, FOR SOLUTION in 1 VIAL (66794-251-02)
11-Digit Billing Format
66794025141
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
5000 EA
Clinical Specifications
Proprietary Name
Erythromycin Lactobionate
Non-Proprietary Name
Erythromycin Lactobionate
Substance Name
Erythromycin Lactobionate
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
Intravenous - Administration within or into a vein or veins.
Usage Information
Erythromycin lactobionate for injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. Intravenous therapy should be replaced by oral administration at the appropriate time.Upper respiratory tract infections of mild to moderate degree caused by
Streptococcus pyogenes (Group A beta-hemolytic streptococci);
Streptococcus pneumoniae (Diplococcus pneumoniae); Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H
. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information).
Lower respiratory tract infections of mild to moderate severity caused by
Streptococcus pyogenes (Group A beta-hemolytic streptococci);
Streptococcus pneumoniae (Diplococcus pneumoniae).Respiratory tract infections due to
Mycoplasma pneumoniae.
Skin and skin structure infections of mild to moderate severity caused by
Streptococcus pyogenes and
Staphylococcus aureus (resistant staphylococci may emerge during treatment).
Diphtheria: As an adjunct to antitoxin infections due to
Corynebacterium diphtheriae to prevent establishment of carriers and to eradicate the organism in carriers.
Erythrasma: In the treatment of infections due to
Corynebacterium minutissimum.
Acute pelvic inflammatory disease caused by
Neisseria gonorrhoeae: Erythromycin lactobionate for injection, USP followed by erythromycin stearate or erythromycin base orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by
N. gonorrhoeae in female patients with a history of sensitivity to penicillin.
Before treatment of gonorrhea, patients who are suspected of also having syphilis should have a microscopic examination for
T. pallidum (by immunofluorescence or darkfield) before receiving erythromycin and monthly serologic tests for a minimum of 4 months thereafter.
Legionnaires’ Disease caused by
Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted,
in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires’ Disease.
Prevention of Initial Attacks of Rheumatic FeverPenicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Group A beta-hemolytic streptococcal infections of the upper respiratory tract e.g., tonsillitis, or pharyngitis).
1 Erythromycin is indicated for the treatment of penicillin-allergic patients. The therapeutic dose should be administered for ten days.
Prevention of Recurrent Attacks of Rheumatic FeverPenicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).
1Prevention of Bacterial EndocarditisAlthough no controlled clinical efficacy trials have been conducted, oral erythromycin has been recommended by the American Heart Association for prevention of bacterial endocarditis in penicillin- allergic patients with prosthetic cardiac valves, most congenital cardiac malformations, surgically constructed systemic pulmonary shunts, rheumatic or other acquired valvular dysfunction, idiopathic hypertrophic subaortic stenosis (IHSS), previous history of bacterial endocarditis and mitral valve prolapse with insufficiency when they undergo dental procedures and surgical procedures of the upper respiratory tract.
2To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin and other antibacterial drugs, erythromycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Regulatory & Marketing
Labeler Name
Piramal Critical Care Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA216761
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-13-2026
Listing Expiration
12-31-2027
Hierarchy Structure
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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