NDC 13925-522

Pentamidine Isethionate

Pentamidine Isethionate

Pentamidine Isethionate is a Respiratory (inhalation) Inhalant in the Human Prescription Drug category. It is labeled and distributed by Seton Pharmaceuticals. The primary component is Pentamidine Isethionate.

Product ID13925-522_dfd8aaea-3825-4a52-80c7-a9a55328586e
NDC13925-522
Product TypeHuman Prescription Drug
Proprietary NamePentamidine Isethionate
Generic NamePentamidine Isethionate
Dosage FormInhalant
Route of AdministrationRESPIRATORY (INHALATION)
Marketing Start Date2019-10-14
Marketing CategoryANDA / ANDA
Application NumberANDA206667
Labeler NameSeton Pharmaceuticals
Substance NamePENTAMIDINE ISETHIONATE
Active Ingredient Strength300 mg/300mg
Pharm ClassesAntiprotozoal [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 13925-522-01

1 VIAL in 1 CARTON (13925-522-01) > 300 mg in 1 VIAL
Marketing Start Date2019-10-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13925-522-01 [13925052201]

Pentamidine Isethionate INHALANT
Marketing CategoryANDA
Application NumberANDA206667
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-10-14

Drug Details

Active Ingredients

IngredientStrength
PENTAMIDINE ISETHIONATE300 mg/300mg

OpenFDA Data

SPL SET ID:c484f16e-9d97-4416-84a4-8ad8deaf5e19
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861597

    • Pharmacological Class

    • Antiprotozoal [EPC]
    • Antiprotozoal [EPC]

    NDC Crossover Matching brand name "Pentamidine Isethionate" or generic name "Pentamidine Isethionate"

    NDCBrand NameGeneric Name
    13925-515Pentamidine IsethionatePentamidine Isethionate
    13925-522Pentamidine IsethionatePentamidine Isethionate
    23155-748pentamidine isethionatepentamidine isethionate
    39822-3050PENTAMIDINE ISETHIONATEPENTAMIDINE ISETHIONATE
    63323-877NebuPentPENTAMIDINE ISETHIONATE
    63323-113Pentam 300PENTAMIDINE ISETHIONATE
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.