Ceftriaxone Sodium Injection, Powder, For Solution
NDC 76420-596

Ceftriaxone Sodium 500 mg/1 · Injection, Powder, For Solution (intramuscular; intravenous)
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 76420-596?
  4. Ceftriaxone Sodium Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Pharmacologic Classes

Product Information

Ceftriaxone Sodium is a ANDA-approved product labeled by Asclemed Usa, Inc.. This medication is typically used as a cephalosporin antibacterial [epc]. It is supplied as a injection, powder, for solution for intramuscular; intravenous administration. This product entry covers the primary NDC 76420-596 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
76420-596
Proprietary Name:
Ceftriaxone Sodium
Non-Proprietary Name: [1]
Ceftriaxone Sodium
Substance Name: [2]
Ceftriaxone Sodium
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

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]
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.

Labeler & Regulatory Data

Labeler Name: [5]
Asclemed Usa, Inc.
Labeler Code:
76420
Product Label ID:
f01cf0e5-caaf-4759-ba21-50f3aceff523
FDA Application Number: [6]
ANDA203702
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
06-30-2017
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 76420-596?

The NDC code 76420-596 is assigned by the FDA to the product Ceftriaxone Sodium. This pharmaceutical product is labeled by Asclemed Usa, Inc. and is currently categorized as listed product. The medication is a injection, powder, for solution administered via intramuscular; intravenous route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 76420-596-01, 76420-596-10. 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?

Before instituting treatment with Ceftriaxone for injection, USP, appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Therapy may be instituted prior to obtaining results of susceptibility testing.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ceftriaxone for injection, USP and other antibacterial drugs, Ceftriaxone for injection, USP 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.Ceftriaxone for injection, USP is indicated for the treatment of the following infections when caused by susceptible organisms:LOWER RESPIRATORY TRACT INFECTIONScaused by Streptococcus pneumoniae, Staphylococcus aureus, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Escherichia coli, Enterobacter aerogenes, Proteus mirabilisor Serratia marcescens.ACUTE BACTERIAL OTITIS MEDIAcaused by Streptococcuspneumoniae,Haemophilus influenzae(including beta-lactamase producing strains) or Moraxella catarrhalis(including beta-lactamase producing strains). NOTE: In one study lower clinical cure rates were observed with a single dose of Ceftriaxone for injection, USP compared to 10 days of oral therapy. In a second study comparable cure rates were observed between single dose Ceftriaxone for injection, USP and the comparator. The potentially lower clinical cure rate of Ceftriaxone for injection, USP should be balanced against the potential advantages of parenteral therapy (see CLINICAL STUDIES). SKIN AND SKIN STRUCTURE INFECTIONScaused by Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Viridans group streptococci, Escherichia coli, Enterobacter cloacae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Morganella morganii,*Pseudomonas aeruginosa, Serratia marcescens, Acinetobacter calcoaceticus, Bacteroides fragilis*or Peptostreptococcusspecies. URINARY TRACT INFECTIONS (complicated and uncomplicated)caused by Escherichia coli, Proteus mirabilis, Proteus vulgaris, Morganella morganiior Klebsiella pneumoniae.UNCOMPLICATED GONORRHEA (cervical/urethral and rectal)caused by Neisseria gonorrhoeae,including both penicillinase- and nonpenicillinase-producing strains, and pharyngeal gonorrhea caused by nonpenicillinase-producing strains of Neisseria gonorrhoeae.PELVIC INFLAMMATORY DISEASEcaused by Neisseria gonorrhoeae.Ceftriaxone for injection, USP, like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are used in the treatment of patients with pelvic inflammatory disease and Chlamydia trachomatisis one of the suspected pathogens, appropriate antichlamydial coverage should be added. BACTERIAL SEPTICEMIAcaused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzaeor Klebsiella pneumoniae.BONE AND JOINT INFECTIONScaused by Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniaeor Enterobacterspecies. INTRA-ABDOMINAL INFECTIONScaused by Escherichia coli, Klebsiella pneumoniae, Bacteroides fragilis, Clostridiumspecies (Note: most strains of Clostridium difficileare resistant) or Peptostreptococcusspecies. MENINGITIScaused by Haemophilus influenzae, Neisseria meningitidisor Streptococcus pneumoniae.Ceftriaxone for injection, USP has also been used successfully in a limited number of cases of meningitis and shunt infection caused by Staphylococcus epidermidis*and Escherichia coli.** Efficacy for this organism in this organ system was studied in fewer than ten infections.

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.
  • CEFTRIAXONE SODIUM 500 mg/1 - A broad-spectrum cephalosporin antibiotic and cefotaxime derivative with a very long half-life and high penetrability to meninges, eyes and inner ears.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

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 indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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".