NDC 13925-515

Pentamidine Isethionate

Pentamidine Isethionate

Pentamidine Isethionate is a Intramuscular; Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Seton Pharmaceuticals. The primary component is Pentamidine Isethionate.

Product ID13925-515_589fcce2-fa9a-4dc0-a79b-ae87cd024365
NDC13925-515
Product TypeHuman Prescription Drug
Proprietary NamePentamidine Isethionate
Generic NamePentamidine Isethionate
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA206666
Labeler NameSeton Pharmaceuticals
Substance NamePENTAMIDINE ISETHIONATE
Active Ingredient Strength300 mg/300mg
Pharm ClassesAntiprotozoal [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 13925-515-10

10 VIAL in 1 TRAY (13925-515-10) > 300 mg in 1 VIAL
Marketing Start Date2018-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13925-515-10 [13925051510]

Pentamidine Isethionate INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA206666
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-01

Drug Details

Active Ingredients

IngredientStrength
PENTAMIDINE ISETHIONATE300 mg/300mg

OpenFDA Data

SPL SET ID:cb8e8155-5505-44d5-9dee-525e2e45b95d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861601
  • UPC Code
  • 0313925515109
  • Pharmacological Class

    • 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

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