pentam 300

Generic: pentamidine isethionate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pentam 300
Generic Name pentamidine isethionate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

pentamidine isethionate 300 mg/3mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-113
Product ID 63323-113_5fe83fb0-2b64-40a2-a996-aaa6292e661e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019264
Listing Expiration 2026-12-31
Marketing Start 2001-01-16

Pharmacologic Class

Classes
antiprotozoal [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323113
Hyphenated Format 63323-113

Supplemental Identifiers

RxCUI
861601 861604
UPC
0363323113018
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 pentam 300 (source: ndc)
Generic Name pentamidine isethionate (source: ndc)
Application Number NDA019264 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/3mL
source: ndc
Packaging
  • 10 VIAL in 1 TRAY (63323-113-10) / 3 mL in 1 VIAL (63323-113-01)
source: ndc

Packages (1)

63323-113-10 10 VIAL in 1 TRAY (63323-113-10) / 3 mL in 1 VIAL (63323-113-01)

Ingredients (1)

pentamidine isethionate (300 mg/3mL)

Linked Drug Pages (1)

Pentam 300 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "5fe83fb0-2b64-40a2-a996-aaa6292e661e", "openfda": {"upc": ["0363323113018"], "unii": ["V2P3K60DA2"], "rxcui": ["861601", "861604"], "spl_set_id": ["cc2b635e-4840-4dc3-a177-5484371680e8"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (63323-113-10)  / 3 mL in 1 VIAL (63323-113-01)", "package_ndc": "63323-113-10", "marketing_start_date": "20010116"}], "brand_name": "Pentam 300", "product_id": "63323-113_5fe83fb0-2b64-40a2-a996-aaa6292e661e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Antiprotozoal [EPC]"], "product_ndc": "63323-113", "generic_name": "PENTAMIDINE ISETHIONATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Pentam 300", "active_ingredients": [{"name": "PENTAMIDINE ISETHIONATE", "strength": "300 mg/3mL"}], "application_number": "NDA019264", "marketing_category": "NDA", "marketing_start_date": "20010116", "listing_expiration_date": "20261231"}