palonosetron hydrochloride

Generic: palonosetron hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

palonosetron hydrochloride .05 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-783
Product ID 25021-783_5679dbc2-6417-4a54-a627-7f72293879ad
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204289
Listing Expiration 2026-12-31
Marketing Start 2018-06-15

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 25021783
Hyphenated Format 25021-783

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 ANDA204289 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .05 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-783-05) / 5 mL in 1 VIAL
source: ndc

Packages (1)

25021-783-05 1 VIAL in 1 CARTON (25021-783-05) / 5 mL in 1 VIAL

Ingredients (1)

palonosetron hydrochloride (.05 mg/mL)

Linked Drug Pages (1)

palonosetron hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "5679dbc2-6417-4a54-a627-7f72293879ad", "openfda": {"unii": ["23310D4I19"], "rxcui": ["1728055"], "spl_set_id": ["6e60d03d-eae6-4924-a507-e77ea077c1ab"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-783-05)  / 5 mL in 1 VIAL", "package_ndc": "25021-783-05", "marketing_start_date": "20180615"}], "brand_name": "palonosetron hydrochloride", "product_id": "25021-783_5679dbc2-6417-4a54-a627-7f72293879ad", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "25021-783", "generic_name": "palonosetron hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "palonosetron hydrochloride", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".05 mg/mL"}], "application_number": "ANDA204289", "marketing_category": "ANDA", "marketing_start_date": "20180615", "listing_expiration_date": "20261231"}