NDC 63323-113

Pentam 300

Pentamidine Isethionate

Pentam 300 is a Intramuscular; Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by App Pharmaceuticals, Llc. The primary component is Pentamidine Isethionate.

Product ID63323-113_2cd3bffe-b3ad-4a79-b782-6880ee48afb0
NDC63323-113
Product TypeHuman Prescription Drug
Proprietary NamePentam 300
Generic NamePentamidine Isethionate
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2001-01-16
Marketing CategoryNDA / NDA
Application NumberNDA019264
Labeler NameAPP Pharmaceuticals, LLC
Substance NamePENTAMIDINE ISETHIONATE
Active Ingredient Strength300 mg/3mL
Pharm ClassesAntiprotozoal [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-113-10

10 VIAL in 1 TRAY (63323-113-10) > 3 mL in 1 VIAL (63323-113-01)
Marketing Start Date2001-01-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-113-10 [63323011310]

Pentam 300 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA019264
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-01-16

Drug Details

Active Ingredients

IngredientStrength
PENTAMIDINE ISETHIONATE300 mg/3mL

OpenFDA Data

SPL SET ID:cc2b635e-4840-4dc3-a177-5484371680e8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 861601
  • 861604
  • UPC Code
  • 0363323113100
  • Pharmacological Class

    • Antiprotozoal [EPC]

    NDC Crossover Matching brand name "Pentam 300" or generic name "Pentamidine Isethionate"

    NDCBrand NameGeneric Name
    63323-113Pentam 300PENTAMIDINE ISETHIONATE
    63323-877NebuPentPENTAMIDINE ISETHIONATE
    13925-515Pentamidine IsethionatePentamidine Isethionate
    13925-522Pentamidine IsethionatePentamidine Isethionate
    23155-748pentamidine isethionatepentamidine isethionate
    39822-3050PENTAMIDINE ISETHIONATEPENTAMIDINE ISETHIONATE

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