Home NDC 68001-355 Palonosetron
Product NDC 68001-355
11-digit product format 680010355
Labeler code 68001
Product ID 68001-355_2cefd5b7-b32d-7b91-e063-6394a90af3b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Palonosetron
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler BluePoint Laboratories
Application ANDA201533
Marketing category ANDA
Marketing start 2018-05-30
Substance PALONOSETRON HYDROCHLORIDE
Active strength .05 mg/mL
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 A201533-001 PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS 2016-04-21 A201533-002 PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP RS 2016-04-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201533-002 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 A201533-001 PALONOSETRON HYDROCHLORIDE EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS 2016-04-21 a50c72e98297…2026-08-01 22:54:32 2026-06 A201533-002 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP RS 2016-04-21 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 A201533-002 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 · 3 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 .05 mg/mL
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 68001-355-25 Palonosetron 1 in 1 CARTON INJECTION, SOLUTION 1 7 68001-355-25 Palonosetron 5 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 5 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68001-355 PALONOSETRON INJECTION, SOLUTION [BLUEPOINT LABORATORIES] 7 Current NDC, Legacy NDC, 2 package rows 20250131_ee6f6f94-1ca7-481e-9909-b19ae64e80c2.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68001-355-25 68001035525 1 VIAL, SINGLE-USE in 1 CARTON (68001-355-25) / 5 mL in 1 VIAL, SINGLE-USE 2018-05-30 0000-00-00 No No Current