Home NDC 71288-409 Palonosetron Hydrochloride
Product NDC 71288-409
11-digit product format 712880409
Labeler code 71288
Product ID 71288-409_a1f0c351-fcb5-4d19-94b1-3317b70be391
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Palonosetron Hydrochloride
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA215861
Marketing category ANDA
Marketing start 2023-08-14
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215861-001 PALONOSETRON HYDROCHLORIDE PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215861-001 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 2026-08-18 06:07:40 2026-07 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215861-001 PALONOSETRON HYDROCHLORIDE EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2023-08-14 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Palonosetron Hydrochloride
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 71288-409-05 Palonosetron Hydrochloride 1 in 1 CARTON INJECTION, SOLUTION 1 4 71288-409-05 Palonosetron Hydrochloride 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-409 PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 4 Current NDC, 2 package rows 20230818_11bb07b2-6530-45ab-a916-ba9dd3107fc3.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71288-409-05 71288040905 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-409-05) / 5 mL in 1 VIAL, SINGLE-DOSE 2023-08-14 No No Current