NDC Package 44001-321-05 Factive

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

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

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

44001-321-05

Package Description:

5 TABLET in 1 BLISTER PACK

Product Code:

44001-321

Proprietary Name:

Factive

Usage Information:

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.

11-Digit NDC Billing Format:

44001032105

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

5 EA

NDC to RxNorm Crosswalk:

RxCUI: 637560 - gemifloxacin mesylate 320 MG Oral Tablet

RxCUI: 637560 - gemifloxacin 320 MG Oral Tablet

RxCUI: 637562 - Factive 320 MG Oral Tablet

RxCUI: 637562 - gemifloxacin 320 MG Oral Tablet [Factive]

RxCUI: 637562 - Factive 320 MG (as gemifloxacin mesylate) Oral Tablet

Labeler Name:

Merus Labs International Inc.

Sample Package:

Start Marketing Date:

04-04-2003

Listing Expiration Date:

12-31-2017

Exclude Flag:

Code Structure:

44001 - Merus Labs International Inc.
- 44001-321 - Factive
  - 44001-321-05 - 5 TABLET in 1 BLISTER PACK

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.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
44001-321-07	7 TABLET in 1 BLISTER PACK

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 44001-321-05?

The NDC Packaged Code 44001-321-05 is assigned to a package of 5 tablet in 1 blister pack of Factive, labeled by Merus Labs International Inc.. The product's dosage form is and is administered via form.This product is billed for "EA" each discreet unit and contains an estimated amount of 5 billable units per package.

Is NDC 44001-321 included in the NDC Directory?

No, Factive with product code 44001-321 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Merus Labs International Inc. on April 04, 2003 and its listing in the NDC Directory is set to expire on December 31, 2017 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 44001-321-05?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 5.

What is the 11-digit format for NDC 44001-321-05?

The 11-digit format is 44001032105. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	44001-321-05	5-4-2	44001-0321-05

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