Factive
NDC 44001-321

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 44001-321?
  5. Factive Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Factive is a NDA-approved product labeled by Merus Labs International 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 44001-321 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
44001-321
Proprietary Name:
Factive
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Merus Labs International Inc.
Labeler Code:
44001
Product Label ID:
63f60426-e27f-4258-9bfc-b4a15ebdca83
FDA Application Number: [6]
NDA021158
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
04-04-2003
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape:
OVAL (C48345)
Size(s):
16 MM
Imprint(s):
GE;320
Score:
2

Code Structure Chart

Product Details

What is NDC 44001-321?

The NDC code 44001-321 is assigned by the FDA to the product Factive. This pharmaceutical product is labeled by Merus Labs International Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 44001-321-05, 44001-321-07. 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?

FACTIVE is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (See DOSAGE AND ADMINISTRATION and CLINICAL STUDIES. )Acute bacterial exacerbation of chronic bronchitis (ABECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.Because fluoroquinolones, including FACTIVE, have been associated with serious adverse reactions (see WARNINGS) and for some patients ABECB is self-limiting, reserve FACTIVE for treatment of ABECB in patients who have no alternative treatment options.Community-acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP])*, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.*MDRSP: multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ≥2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.To reduce the development of drug-resistant bacteria and maintain the effectiveness of FACTIVE and other antibacterial drugs, FACTIVE should be used only to treat 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.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive 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:

* Please review the full disclaimer at the bottom of this page.

Patient Education

Gemifloxacin


Gemifloxacin is used to treat pneumonia. Gemifloxacin may also be used to treat bronchitis but should not be used for this condition if there are other treatment options. Gemifloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics such as gemifloxacin do not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
[Learn More]


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:

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:

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


[Learn More]


* 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 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".