palonosetron hydrochloride

Generic: palonosetron hydrochloride

Labeler: avenacy, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name palonosetron hydrochloride
Generic Name palonosetron hydrochloride
Labeler avenacy, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

palonosetron hydrochloride .05 mg/mL

Manufacturer
Avenacy, Inc.

Identifiers & Regulatory

Product NDC 83634-777
Product ID 83634-777_2b7c65dc-88e9-4e1d-8751-43ff4878d913
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202951
Listing Expiration 2026-12-31
Marketing Start 2024-05-15

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 83634777
Hyphenated Format 83634-777

Supplemental Identifiers

RxCUI
1728055
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 hydrochloride (source: ndc)
Generic Name palonosetron hydrochloride (source: ndc)
Application Number ANDA202951 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .05 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (83634-777-05) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

83634-777-05 1 VIAL, SINGLE-DOSE in 1 CARTON (83634-777-05) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

palonosetron hydrochloride (.05 mg/mL)

Linked Drug Pages (1)

Palonosetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2b7c65dc-88e9-4e1d-8751-43ff4878d913", "openfda": {"unii": ["23310D4I19"], "rxcui": ["1728055"], "spl_set_id": ["0063b66a-a71b-473c-97b8-7c59f2a5b18e"], "manufacturer_name": ["Avenacy, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83634-777-05)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83634-777-05", "marketing_start_date": "20240515"}], "brand_name": "Palonosetron Hydrochloride", "product_id": "83634-777_2b7c65dc-88e9-4e1d-8751-43ff4878d913", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "83634-777", "generic_name": "palonosetron hydrochloride", "labeler_name": "Avenacy, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Palonosetron Hydrochloride", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".05 mg/mL"}], "application_number": "ANDA202951", "marketing_category": "ANDA", "marketing_start_date": "20240515", "listing_expiration_date": "20261231"}