Erythromycin Lactobionate Injection, Powder, For Solution
NDC 66794-251
Erythromycin Lactobionate 500 mg/1 · Injection, Powder, For Solution (intravenous)
Product Information
Erythromycin Lactobionate is a ANDA-approved product labeled by Piramal Critical Care Inc.. This medication is typically used as a decreased sebaceous gland activity [pe]. It is supplied as a injection, powder, for solution for intravenous administration. This product entry covers the primary NDC 66794-251 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
66794-251
Proprietary Name:
Erythromycin Lactobionate
Non-Proprietary Name: [1]
Erythromycin Lactobionate
Substance Name: [2]
Erythromycin Lactobionate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications
Dosage Form:
Injection, Powder, For Solution
- A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route(s): [4]
Intravenous - Administration within or into a vein or veins.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
66794
Product Label ID:
FDA Application Number: [6]
ANDA216761
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
08-13-2026
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N
Code Structure Chart
Product Details
What is NDC 66794-251?
The NDC code 66794-251 is assigned by the FDA to the product Erythromycin Lactobionate. This pharmaceutical product is labeled by Piramal Critical Care Inc. and is currently categorized as listed product. The medication is a injection, powder, for solution administered via intravenous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 66794-251-41. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
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.
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- ERYTHROMYCIN LACTOBIONATE (UNII: 33H58I7GLQ)
- ERYTHROMYCIN (UNII: 63937KV33D) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:
- RxCUI: 1668264 - erythromycin lactobionate 500 MG Injection
Which are the Pharmacologic Classes of this product?
A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.
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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
