palonosetron hydrochloride

Generic: palonosetron hydrochloride

Labeler: teva parenteral medicines, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name palonosetron hydrochloride
Generic Name palonosetron hydrochloride
Labeler teva parenteral medicines, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

palonosetron hydrochloride .25 mg/5mL

Manufacturer
Teva Parenteral Medicines, Inc.

Identifiers & Regulatory

Product NDC 0703-4094
Product ID 0703-4094_4ab2e965-912b-4a1c-80e7-a07217c96d35
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090713
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 07034094
Hyphenated Format 0703-4094

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 ANDA090713 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .25 mg/5mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0703-4094-01) / 5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

0703-4094-01 1 VIAL, SINGLE-USE in 1 CARTON (0703-4094-01) / 5 mL in 1 VIAL, SINGLE-USE

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": "4ab2e965-912b-4a1c-80e7-a07217c96d35", "openfda": {"unii": ["23310D4I19"], "rxcui": ["1728055"], "spl_set_id": ["911783eb-91a8-4ef4-bd6f-809211e207d6"], "manufacturer_name": ["Teva Parenteral Medicines, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0703-4094-01)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0703-4094-01", "marketing_start_date": "20180323"}], "brand_name": "Palonosetron Hydrochloride", "product_id": "0703-4094_4ab2e965-912b-4a1c-80e7-a07217c96d35", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "0703-4094", "generic_name": "Palonosetron Hydrochloride", "labeler_name": "Teva Parenteral Medicines, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Palonosetron Hydrochloride", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".25 mg/5mL"}], "application_number": "ANDA090713", "marketing_category": "ANDA", "marketing_start_date": "20180323", "listing_expiration_date": "20261231"}