Erythromycin Ethylsuccinate for suspensions is to reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. This formulation utilizes a for suspension delivery system. Marketed by Cadila Pharmaceuticals Limited, this product is identified by NDC 71209-102 and is authorized under FDA application ANDA216212.
Identification & Billing
NDC Package Code
71209-102-21
Package Description
100 mL in 1 BOTTLE
11-Digit Billing Format
71209010221
RxNorm Crosswalk
- RxCUI: 686400 - erythromycin ethylsuccinate 200 MG in 5 mL Oral Suspension
- RxCUI: 686400 - erythromycin ethylsuccinate 40 MG/ML Oral Suspension
- RxCUI: 686400 - EES 40 MG/ML Oral Suspension
- RxCUI: 686400 - erythromycin ethylsuccinate 200 MG per 5 ML Oral Suspension
- RxCUI: 686418 - erythromycin ethylsuccinate 400 MG in 5 mL Oral Suspension
Clinical Specifications
Proprietary Name
Erythromycin Ethylsuccinate
Non-Proprietary Name
Erythromycin Ethylsuccinate
Substance Name
Erythromycin Ethylsuccinate
Dosage Form
For Suspension - A product, usually a solid, intended for suspension prior to administration.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension 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.Erythromycin ethylsuccinate for oral suspension is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below:Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or 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 pneumoniae or Streptococcus pyogenes.Listeriosis caused by Listeria monocytogenes. Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious. Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals.Respiratory tract infections due to Mycoplasma pneumoniae. Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).Diphtheria Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers.Erythrasma In the treatment of infections due to Corynebacterium minutissimum. Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis requires treatment with other agents.Acute Pelvic Inflammatory Disease Caused by Neisseria gonorrhoeae 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. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.Syphilis Caused by Treponema pallidum Erythromycin is an alternate choice of treatment for primary syphilis in penicillin-allergic patients. In primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy.Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis Conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis. When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum. 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.Prophylaxis Prevention of Initial Attacks of Rheumatic Fever Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper respiratory tract, e.g., tonsillitis or pharyngitis). Erythromycin is indicated for the treatment of penicillin-allergic patients.1 The therapeutic dose should be administered for 10 days.Prevention of Recurrent Attacks of Rheumatic Fever Penicillin 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).1
Regulatory & Marketing
Labeler Name
Cadila Pharmaceuticals Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA216212
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-21-2022
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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