palonosetron

Generic: palonosetron

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name palonosetron
Generic Name palonosetron
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

palonosetron hydrochloride .25 mg/5mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-673
Product ID 63323-673_a118bce3-a56b-4c7a-bb02-2c32abea5b0d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206802
Listing Expiration 2026-12-31
Marketing Start 2018-09-19

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 63323673
Hyphenated Format 63323-673

Supplemental Identifiers

RxCUI
1728055
UPC
0363323673055
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 (source: ndc)
Generic Name palonosetron (source: ndc)
Application Number ANDA206802 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-673-05) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

63323-673-05 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-673-05) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

palonosetron hydrochloride (.25 mg/5mL)

Linked Drug Pages (2)

Palonosetron ndc-match (0.9) PALONOSETRON ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "a118bce3-a56b-4c7a-bb02-2c32abea5b0d", "openfda": {"upc": ["0363323673055"], "unii": ["23310D4I19"], "rxcui": ["1728055"], "spl_set_id": ["9132366b-b808-46c9-b167-c1900bc116b3"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (63323-673-05)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63323-673-05", "marketing_start_date": "20180919"}], "brand_name": "PALONOSETRON", "product_id": "63323-673_a118bce3-a56b-4c7a-bb02-2c32abea5b0d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "63323-673", "generic_name": "Palonosetron", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PALONOSETRON", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".25 mg/5mL"}], "application_number": "ANDA206802", "marketing_category": "ANDA", "marketing_start_date": "20180919", "listing_expiration_date": "20261231"}