Home NDC 83831-105 posfrea
Product NDC 83831-105
11-digit product format 838310105
Labeler code 83831
Product ID 83831-105_2f9cbcbc-86ee-49e4-a98a-d7fa286a32b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name palonosetron
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Avyxa Pharma, LLC
Application NDA203050
Marketing category NDA
Marketing start 2024-09-30
Substance PALONOSETRON HYDROCHLORIDE
Active strength .25 mg/5mL
Pharmacologic classes Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203050-001 POSFREA PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2016-03-01 N203050-002 POSFREA PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-01
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 N203050-001 POSFREA EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD 2016-03-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N203050-002 POSFREA EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2016-03-01 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base posfrea
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PALONOSETRON HYDROCHLORIDE .25 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 23310D4I19 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1728050 Internal RxNorm lookup 1728055 Internal RxNorm lookup 2688837 Internal RxNorm lookup 2688839 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83831-105-01 posfrea 1 in 1 CARTON INJECTION, SOLUTION 1 7 83831-105-01 posfrea 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83831-105 POSFREA (PALONOSETRON) INJECTION, SOLUTION [AVYXA PHARMA, LLC] 7 Current NDC, 2 package rows 20250430_13a201ba-c86d-48c5-a0e1-a3e0b4e6a2a7.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83831-105-01 83831010501 1 VIAL, SINGLE-DOSE in 1 CARTON (83831-105-01) / 5 mL in 1 VIAL, SINGLE-DOSE 2024-09-30 No No Current