NDC 63323-877

NebuPent

Pentamidine Isethionate

NebuPent is a Respiratory (inhalation) Inhalant in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Pentamidine Isethionate.

• Product ID: 63323-877_9d14a7f6-afab-40d6-b3d2-4ebe8bed0605
• NDC: 63323-877
• Product Type: Human Prescription Drug
• Proprietary Name: NebuPent
• Generic Name: Pentamidine Isethionate
• Dosage Form: Inhalant
• Route of Administration: RESPIRATORY (INHALATION)
• Marketing Start Date: 2011-02-15
• Marketing Category: NDA / NDA
• Application Number: NDA019887
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: PENTAMIDINE ISETHIONATE
• Active Ingredient Strength: 300 mg/6mL
• Pharm Classes: Antiprotozoal [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63323-877-15

1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) > 6 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2011-02-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-877-15 [63323087715]

NebuPent INHALANT

• Marketing Category: NDA
• Application Number: NDA019887
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-02-15

Drug Details

Active Ingredients

Ingredient	Strength
PENTAMIDINE ISETHIONATE	300 mg/6mL

OpenFDA Data

• SPL SET ID: e2ad9d3c-b6c3-4f70-87e0-722a8ff94ccb
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • V2P3K60DA2
• RxNorm Concept Unique ID - RxCUI:
  • 861599
  • 861597

Pharmacological Class

• Antiprotozoal [EPC]

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

NDC	Brand Name	Generic Name
63323-877	NebuPent	PENTAMIDINE ISETHIONATE
63323-113	Pentam 300	PENTAMIDINE ISETHIONATE
13925-515	Pentamidine Isethionate	Pentamidine Isethionate
13925-522	Pentamidine Isethionate	Pentamidine Isethionate
23155-748	pentamidine isethionate	pentamidine isethionate
39822-3050	PENTAMIDINE ISETHIONATE	PENTAMIDINE ISETHIONATE