Home NDC 60505-6439 Palonosetron
Product NDC 60505-6439
11-digit product format 605056439
Labeler code 60505
Product ID 60505-6439_77da1c6e-4a91-4042-a227-57904bbe2f07
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Palonosetron Hydrochloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Apotex Corp.
Application ANDA205648
Marketing category ANDA
Marketing start 2025-10-24
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 A205648-001 PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2018-09-19 A205648-002 PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS 2018-09-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205648-001 AP
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 A205648-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2018-09-19 a50c72e98297…2026-08-01 22:54:32 2026-06 A205648-002 PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS 2018-09-19 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A205648-001 AP 1 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 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Palonosetron
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1728055 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 60505-6439-1 Palonosetron 5 mL in 1 VIAL INJECTION 5 2 60505-6439-1 Palonosetron 1 in 1 CARTON INJECTION 1 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-6439-1 60505643901 1 VIAL in 1 CARTON (60505-6439-1) / 5 mL in 1 VIAL 1 vial 2025-10-31 No No Current