Ampicillin
NDC 0404-9816
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
Ampicillin is a ANDA-approved product labeled by Henry Schein, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white product. This product entry covers the primary NDC 0404-9816 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
0404-9816
Proprietary Name:
Ampicillin
Product Type: [3]
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
0404
Product Label ID:
FDA Application Number: [6]
ANDA065499
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
01-08-2022
End Marketing Date: [10]
04-30-2026
Listing Expiration Date: [11]
04-30-2026
Exclude Flag: [12]
D
Product Characteristics
Color(s):
WHITE (C48325)
Code Structure Chart
Product Details
What is NDC 0404-9816?
The NDC code 0404-9816 is assigned by the FDA to the product Ampicillin. This pharmaceutical product is labeled by Henry Schein, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0404-9816-99. 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?
Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:Respiratory Tract Infections caused by Streptococcus pneumoniae, Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae, and Group A beta-hemolytic streptococci.Bacterial Meningitis caused by E. coli, Group B streptococci, and other Gram-negative bacteria (Listeria monocytogenes, N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria.Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus spp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella spp. responds to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis.Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis.Gastrointestinal Infections caused by Salmonella typhi (typhoid fever), other Salmonella spp., and Shigella spp. (dysentery) usually respond to oral or intravenous therapy.Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing. It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin 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.Indicated surgical procedures should be performed.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- AMPICILLIN SODIUM (UNII: JFN36L5S8K)
- AMPICILLIN (UNII: 7C782967RD) (Active Moiety)
* Please review the full disclaimer at the bottom of this page.
Patient Education
Ampicillin Injection
Ampicillin injection is used to treat certain infections that are caused by bacteria such as meningitis (infection of the membranes that surround the brain and spinal cord) and lung, blood, heart, urinary tract, and gastrointestinal tract infections. Ampicillin injection is in a class of medications called penicillins. It works by killing bacteria. Antibiotics such as ampicillin injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
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Antibiotics
What are antibiotics?
Antibiotics are medicines that fight bacterial infections in people and animals. They work by killing the bacteria or by making it hard for the bacteria to grow and multiply.
Antibiotics can be taken in different ways:
- Orally (by mouth). This could be pills, capsules, or liquids.
- Topically. This might be a cream, spray, or ointment that you put on your skin. It could also be eye ointment, eye drops, or ear drops.
- Through an injection or intravenously (IV). This is usually for more serious infections.
What do antibiotics treat?
Antibiotics only treat certain bacterial infections, such as strep throat, urinary tract infections, and E. coli.
You may not need to take antibiotics for some bacterial infections. For example, you might not need them for many sinus infections or some ear infections. Taking antibiotics when they're not needed won't help you, and they can have side effects. Your health care provider can decide the best treatment for you when you're sick. Don't ask your provider to prescribe an antibiotic for you.
Do antibiotics treat viral infections?
Antibiotics do not work on viral infections. For example, you shouldn't take antibiotics for:
- Colds and runny noses, even if the mucus is thick, yellow, or green
- Most sore throats (except strep throat)
- Flu
- Most cases of bronchitis
What are the side effects of antibiotics?
The side effects of antibiotics range from minor to very severe. Some of the common side effects include:
More serious side effects can include:
- C. diff infections, which cause diarrhea that can lead to severe colon damage and sometimes even death
- Severe and life-threatening allergic reactions
- Antibiotic resistance infections
Call your health care provider if you develop any side effects while taking your antibiotic.
Why is it important to take antibiotics only when they're needed?
You should only take antibiotics when they are needed because they can cause side effects and can contribute to antibiotic resistance. Antibiotic resistance happens when the bacteria change and become able to resist the effects of an antibiotic. This means that the bacteria continue to grow.
How do I use antibiotics correctly?
When you take antibiotics, it is important that you take them responsibly:
- Always follow the directions carefully. Finish your medicine even if you feel better. If you stop taking them too soon, some bacteria may survive and re-infect you.
- Don't save your antibiotics for later.
- Don't share your antibiotic with others.
- Don't take antibiotics prescribed for someone else. This may delay the best treatment for you, make you even sicker, or cause side effects.
Centers for Disease Control and Prevention
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* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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 End Marketing Date? This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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".
