palonosetron hydrochloride

Generic: palonosetron hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name palonosetron hydrochloride
Generic Name palonosetron hydrochloride
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

palonosetron hydrochloride .25 mg/5mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-317
Product ID 67457-317_4fbe587d-ddb7-42fd-aad9-e749689d2276
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206416
Listing Expiration 2026-12-31
Marketing Start 2018-09-20

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 67457317
Hyphenated Format 67457-317

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 ANDA206416 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-317-25) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

67457-317-25 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-317-25) / 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": "4fbe587d-ddb7-42fd-aad9-e749689d2276", "openfda": {"unii": ["23310D4I19"], "rxcui": ["1728055"], "spl_set_id": ["0a781796-bb74-4c5f-8d26-9ce520b818f7"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (67457-317-25)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "67457-317-25", "marketing_start_date": "20180920"}], "brand_name": "Palonosetron Hydrochloride", "product_id": "67457-317_4fbe587d-ddb7-42fd-aad9-e749689d2276", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "67457-317", "generic_name": "Palonosetron Hydrochloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Palonosetron Hydrochloride", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".25 mg/5mL"}], "application_number": "ANDA206416", "marketing_category": "ANDA", "marketing_start_date": "20180920", "listing_expiration_date": "20261231"}