palonosetron hydrochloride

Generic: palonosetron hydrochloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name palonosetron hydrochloride
Generic Name palonosetron hydrochloride
Labeler baxter healthcare corporation
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

palonosetron hydrochloride .25 mg/5mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 36000-326
Product ID 36000-326_4d54b4d2-3572-4693-bfe1-2550abc5f439
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206916
Listing Expiration 2026-12-31
Marketing Start 2021-11-12

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 36000326
Hyphenated Format 36000-326

Supplemental Identifiers

RxCUI
1728055
UPC
0336000326018
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 ANDA206916 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (36000-326-02) / 5 mL in 1 VIAL (36000-326-01)
source: ndc

Packages (1)

36000-326-02 1 VIAL in 1 CARTON (36000-326-02) / 5 mL in 1 VIAL (36000-326-01)

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": "4d54b4d2-3572-4693-bfe1-2550abc5f439", "openfda": {"upc": ["0336000326018"], "unii": ["23310D4I19"], "rxcui": ["1728055"], "spl_set_id": ["0f3bfe3d-75c8-42eb-84be-570f8e251fdd"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (36000-326-02)  / 5 mL in 1 VIAL (36000-326-01)", "package_ndc": "36000-326-02", "marketing_start_date": "20211112"}], "brand_name": "Palonosetron Hydrochloride", "product_id": "36000-326_4d54b4d2-3572-4693-bfe1-2550abc5f439", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "36000-326", "generic_name": "palonosetron hydrochloride", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Palonosetron Hydrochloride", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".25 mg/5mL"}], "application_number": "ANDA206916", "marketing_category": "ANDA", "marketing_start_date": "20211112", "listing_expiration_date": "20261231"}