palonosetron hydrochloride

Generic: palonosetron hydrochloride

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name palonosetron hydrochloride
Generic Name palonosetron hydrochloride
Labeler cipla usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

palonosetron hydrochloride .25 mg/5mL

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-927
Product ID 69097-927_04460041-adec-463b-ba9d-6a12038ab672
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021372
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 69097927
Hyphenated Format 69097-927

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 NDA021372 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/5mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (69097-927-35) / 5 mL in 1 VIAL
source: ndc

Packages (1)

69097-927-35 1 VIAL in 1 CARTON (69097-927-35) / 5 mL in 1 VIAL

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": "04460041-adec-463b-ba9d-6a12038ab672", "openfda": {"unii": ["23310D4I19"], "rxcui": ["1728055"], "spl_set_id": ["37e7ef89-fd77-44e0-9271-ae91f8822603"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (69097-927-35)  / 5 mL in 1 VIAL", "package_ndc": "69097-927-35", "marketing_start_date": "20180323"}], "brand_name": "palonosetron hydrochloride", "product_id": "69097-927_04460041-adec-463b-ba9d-6a12038ab672", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "69097-927", "generic_name": "palonosetron hydrochloride", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "palonosetron hydrochloride", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".25 mg/5mL"}], "application_number": "NDA021372", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20180323", "listing_expiration_date": "20261231"}