palonosetron hydrochloride

Generic: palonosetron hydrochloride

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name palonosetron hydrochloride
Generic Name palonosetron hydrochloride
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

palonosetron hydrochloride .25 mg/5mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-409
Product ID 71288-409_a1f0c351-fcb5-4d19-94b1-3317b70be391
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215861
Listing Expiration 2026-12-31
Marketing Start 2023-08-14

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 71288409
Hyphenated Format 71288-409

Supplemental Identifiers

RxCUI
1728055
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 palonosetron hydrochloride (source: ndc)
Generic Name palonosetron hydrochloride (source: ndc)
Application Number ANDA215861 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-409-05) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71288-409-05 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-409-05) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

palonosetron hydrochloride (.25 mg/5mL)

Linked Drug Pages (1)

Palonosetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a1f0c351-fcb5-4d19-94b1-3317b70be391", "openfda": {"unii": ["23310D4I19"], "rxcui": ["1728055"], "spl_set_id": ["11bb07b2-6530-45ab-a916-ba9dd3107fc3"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71288-409-05)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "71288-409-05", "marketing_start_date": "20230814"}], "brand_name": "Palonosetron Hydrochloride", "product_id": "71288-409_a1f0c351-fcb5-4d19-94b1-3317b70be391", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "71288-409", "generic_name": "Palonosetron Hydrochloride", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Palonosetron Hydrochloride", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".25 mg/5mL"}], "application_number": "ANDA215861", "marketing_category": "ANDA", "marketing_start_date": "20230814", "listing_expiration_date": "20261231"}