pentamidine isethionate

Generic: pentamidine isethionate

Labeler: xgen pharmaceuticals djb, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pentamidine isethionate
Generic Name pentamidine isethionate
Labeler xgen pharmaceuticals djb, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

pentamidine isethionate 300 mg/3mL

Manufacturer
XGen Pharmaceuticals DJB, Inc.

Identifiers & Regulatory

Product NDC 39822-3050
Product ID 39822-3050_0fcb7bdf-013e-a77c-e063-6394a90ad20f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206982
Listing Expiration 2026-12-31
Marketing Start 2023-04-04

Pharmacologic Class

Classes
antiprotozoal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 398223050
Hyphenated Format 39822-3050

Supplemental Identifiers

RxCUI
861601
UPC
0339822305018
UNII
V2P3K60DA2

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pentamidine isethionate (source: ndc)
Generic Name pentamidine isethionate (source: ndc)
Application Number ANDA206982 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/3mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (39822-3050-2) / 3 mL in 1 VIAL
source: ndc

Packages (1)

39822-3050-2 10 VIAL in 1 CARTON (39822-3050-2) / 3 mL in 1 VIAL

Ingredients (1)

pentamidine isethionate (300 mg/3mL)

Linked Drug Pages (1)

PENTAMIDINE ISETHIONATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "0fcb7bdf-013e-a77c-e063-6394a90ad20f", "openfda": {"upc": ["0339822305018"], "unii": ["V2P3K60DA2"], "rxcui": ["861601"], "spl_set_id": ["860c799c-5199-4f0c-b21b-9910273474d9"], "manufacturer_name": ["XGen Pharmaceuticals DJB, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (39822-3050-2)  / 3 mL in 1 VIAL", "package_ndc": "39822-3050-2", "marketing_start_date": "20230404"}], "brand_name": "PENTAMIDINE ISETHIONATE", "product_id": "39822-3050_0fcb7bdf-013e-a77c-e063-6394a90ad20f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antiprotozoal [EPC]"], "product_ndc": "39822-3050", "generic_name": "PENTAMIDINE ISETHIONATE", "labeler_name": "XGen Pharmaceuticals DJB, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PENTAMIDINE ISETHIONATE", "active_ingredients": [{"name": "PENTAMIDINE ISETHIONATE", "strength": "300 mg/3mL"}], "application_number": "ANDA206982", "marketing_category": "ANDA", "marketing_start_date": "20230404", "listing_expiration_date": "20261231"}