pentamidine isethionate

Generic: pentamidine isethionate

Labeler: seton pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

pentamidine isethionate 300 mg/300mg

Manufacturer
Seton Pharmaceuticals

Identifiers & Regulatory

Product NDC 13925-515
Product ID 13925-515_c83ced5f-9bf2-4367-9146-5b17d0b83371
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206666
Listing Expiration 2026-12-31
Marketing Start 2018-04-01

Pharmacologic Class

Classes
antiprotozoal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13925515
Hyphenated Format 13925-515

Supplemental Identifiers

RxCUI
861601
UPC
0313925515109
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 ANDA206666 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/300mg
source: ndc
Packaging
  • 10 VIAL in 1 TRAY (13925-515-10) / 300 mg in 1 VIAL
source: ndc

Packages (1)

13925-515-10 10 VIAL in 1 TRAY (13925-515-10) / 300 mg in 1 VIAL

Ingredients (1)

pentamidine isethionate (300 mg/300mg)

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": "c83ced5f-9bf2-4367-9146-5b17d0b83371", "openfda": {"upc": ["0313925515109"], "unii": ["V2P3K60DA2"], "rxcui": ["861601"], "spl_set_id": ["cb8e8155-5505-44d5-9dee-525e2e45b95d"], "manufacturer_name": ["Seton Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (13925-515-10)  / 300 mg in 1 VIAL", "package_ndc": "13925-515-10", "marketing_start_date": "20180401"}], "brand_name": "Pentamidine Isethionate", "product_id": "13925-515_c83ced5f-9bf2-4367-9146-5b17d0b83371", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antiprotozoal [EPC]"], "product_ndc": "13925-515", "generic_name": "Pentamidine Isethionate", "labeler_name": "Seton Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pentamidine Isethionate", "active_ingredients": [{"name": "PENTAMIDINE ISETHIONATE", "strength": "300 mg/300mg"}], "application_number": "ANDA206666", "marketing_category": "ANDA", "marketing_start_date": "20180401", "listing_expiration_date": "20261231"}