palonosetron

Generic: palonosetron hydrochloride

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name palonosetron
Generic Name palonosetron hydrochloride
Labeler apotex corp.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

palonosetron hydrochloride .25 mg/5mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-6439
Product ID 60505-6439_77da1c6e-4a91-4042-a227-57904bbe2f07
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205648
Listing Expiration 2026-12-31
Marketing Start 2025-10-24

Pharmacologic Class

Classes
serotonin 3 receptor antagonists [moa] serotonin-3 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056439
Hyphenated Format 60505-6439

Supplemental Identifiers

RxCUI
1728055
UPC
0360505643912
UNII
23310D4I19

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 palonosetron (source: ndc)
Generic Name palonosetron hydrochloride (source: ndc)
Application Number ANDA205648 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (60505-6439-1) / 5 mL in 1 VIAL
source: ndc

Packages (1)

60505-6439-1 1 VIAL in 1 CARTON (60505-6439-1) / 5 mL in 1 VIAL

Ingredients (1)

palonosetron hydrochloride (.25 mg/5mL)

Linked Drug Pages (1)

Palonosetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "77da1c6e-4a91-4042-a227-57904bbe2f07", "openfda": {"upc": ["0360505643912"], "unii": ["23310D4I19"], "rxcui": ["1728055"], "spl_set_id": ["4af600d1-0ab1-41c5-af2f-9dc24cf3c90e"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (60505-6439-1)  / 5 mL in 1 VIAL", "package_ndc": "60505-6439-1", "marketing_start_date": "20251031"}], "brand_name": "Palonosetron", "product_id": "60505-6439_77da1c6e-4a91-4042-a227-57904bbe2f07", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "60505-6439", "generic_name": "Palonosetron Hydrochloride", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Palonosetron", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".25 mg/5mL"}], "application_number": "ANDA205648", "marketing_category": "ANDA", "marketing_start_date": "20251024", "listing_expiration_date": "20261231"}