NDC 51655-159 Amoxicillan
View Dosage, Usage, Ingredients, Routes, UNII
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
51655-159
Proprietary Name:
Amoxicillan
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Northwind Pharmaceuticals,llc
Labeler Code:
51655
Product Label ID:
Start Marketing Date: [9]
07-18-2014
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
- 51655 - Northwind Pharmaceuticals,llc
- 51655-159 - Amoxicillan
Code Navigator:
Product Characteristics
Color(s):
BROWN (C48332)
Shape:
CAPSULE (C48336)
Size(s):
22 MM
Imprint(s):
AA;825
Score:
1
Product Packages
NDC Code 51655-159-03
Package Description: 3 TABLET in 1 BOTTLE, DISPENSING
Product Details
What is NDC 51655-159?
The NDC code 51655-159 is assigned by the FDA to the product Amoxicillan which is product labeled by Northwind Pharmaceuticals,llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 51655-159-03 3 tablet in 1 bottle, dispensing . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.
What are the uses for Amoxicillan?
Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) strains of the designated microorganisms in the conditions listed below:Infections of the ear, nose, and throat - due to Streptococcus spp. (α- and β- hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.Infections of the genitourinary tract - due to E. coli, P. mirabilis, or E. faecalis.Infections of the skin and skin structure - due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli.Infections of the lower respiratory tract - due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.Gonorrhea, acute uncomplicated (ano-genital and urethral infections) - due to N. gonorrhoeae (males and females).H. pylori eradication to reduce the risk of duodenal ulcer recurrence.Triple TherapyAmoxicillin/Clarithromycin/LansoprazoleAmoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.)Dual TherapyAmoxicillin/LansoprazoleAmoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY section.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION sections.)To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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 Amoxicillan UNII Codes?
The UNII codes for the active ingredients in this product are:
- AMOXICILLIN (UNII: 804826J2HU)
- AMOXICILLIN ANHYDROUS (UNII: 9EM05410Q9) (Active Moiety)
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Product Footnotes
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] 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.
[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".