posfrea

Generic: palonosetron

Labeler: avyxa pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name posfrea
Generic Name palonosetron
Labeler avyxa pharma, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

palonosetron hydrochloride .25 mg/5mL

Manufacturer
Avyxa Pharma, LLC

Identifiers & Regulatory

Product NDC 83831-105
Product ID 83831-105_2f9cbcbc-86ee-49e4-a98a-d7fa286a32b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA203050
Listing Expiration 2026-12-31
Marketing Start 2024-09-30

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 83831105
Hyphenated Format 83831-105

Supplemental Identifiers

RxCUI
1728050 1728055 2688837 2688839
UPC
0383831105015
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 posfrea (source: ndc)
Generic Name palonosetron (source: ndc)
Application Number NDA203050 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

83831-105-01 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

palonosetron hydrochloride (.25 mg/5mL)

Linked Drug Pages (1)

posfrea ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "2f9cbcbc-86ee-49e4-a98a-d7fa286a32b8", "openfda": {"upc": ["0383831105015"], "unii": ["23310D4I19"], "rxcui": ["1728050", "1728055", "2688837", "2688839"], "spl_set_id": ["13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7"], "manufacturer_name": ["Avyxa Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "83831-105-01", "marketing_start_date": "20240930"}], "brand_name": "posfrea", "product_id": "83831-105_2f9cbcbc-86ee-49e4-a98a-d7fa286a32b8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "83831-105", "generic_name": "palonosetron", "labeler_name": "Avyxa Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "posfrea", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".25 mg/5mL"}], "application_number": "NDA203050", "marketing_category": "NDA", "marketing_start_date": "20240930", "listing_expiration_date": "20261231"}