palonosetron hydrochloride

Generic: palonosetron hydrochloride

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

palonosetron hydrochloride .25 mg/5mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3415
Product ID 0781-3415_f160a215-5fc0-41bc-9dfb-9dee7ef62388
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202521
Listing Expiration 2026-12-31
Marketing Start 2018-03-23

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 07813415
Hyphenated Format 0781-3415

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 ANDA202521 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-75) / 5 mL in 1 VIAL, SINGLE-DOSE
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-95) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

0781-3415-75 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-75) / 5 mL in 1 VIAL, SINGLE-DOSE 0781-3415-95 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-95) / 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": "f160a215-5fc0-41bc-9dfb-9dee7ef62388", "openfda": {"unii": ["23310D4I19"], "rxcui": ["1728055"], "spl_set_id": ["5bfb3984-2b47-4e06-9bbb-d055ebc376c8"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-75)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0781-3415-75", "marketing_start_date": "20181126"}, {"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3415-95)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0781-3415-95", "marketing_start_date": "20241001"}], "brand_name": "Palonosetron Hydrochloride", "product_id": "0781-3415_f160a215-5fc0-41bc-9dfb-9dee7ef62388", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "0781-3415", "generic_name": "Palonosetron Hydrochloride", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Palonosetron Hydrochloride", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".25 mg/5mL"}], "application_number": "ANDA202521", "marketing_category": "ANDA", "marketing_start_date": "20180323", "listing_expiration_date": "20261231"}