NDC 13925-522 Pentamidine Isethionate

Pentamidine Isethionate

NDC Product Code 13925-522

NDC 13925-522-01

Package Description: 1 VIAL in 1 CARTON > 300 mg in 1 VIAL

NDC Product Information

Pentamidine Isethionate with NDC 13925-522 is a a human prescription drug product labeled by Seton Pharmaceuticals. The generic name of Pentamidine Isethionate is pentamidine isethionate. The product's dosage form is inhalant and is administered via respiratory (inhalation) form.

Labeler Name: Seton Pharmaceuticals

Dosage Form: Inhalant - A special class of inhalations consisting of a drug or combination of drugs, that by virtue of their high vapor pressure can be carried by an air current into the nasal passage where they exert their effect; the container from which the inhalant generally is administered is known as an inhaler.

Product Type: Human Prescription Drug 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.

Pentamidine Isethionate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • PENTAMIDINE ISETHIONATE 300 mg/300mg

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Antiprotozoal - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Seton Pharmaceuticals
Labeler Code: 13925
FDA Application Number: ANDA206667 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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. 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.

Start Marketing Date: 10-14-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Pentamidine Oral Inhalation

Pentamidine Oral Inhalation is pronounced as (pen tam' i deen)

Why is pentamidine oral inhalation medication prescribed?
Pentamidine is an anti-infective agent that helps to treat or prevent pneumonia caused by the organism Pneumocystis jiroveci (carinii).This medication is sometimes prescr...
[Read More]

* Please review the disclaimer below.

Pentamidine Isethionate Product Label Images