palonosetron

Generic: palonosetron

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name palonosetron
Generic Name palonosetron
Labeler northstar rx llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

palonosetron hydrochloride .05 mg/mL

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-834
Product ID 16714-834_8d32d892-2cbb-f22e-0084-b405875974af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201533
Listing Expiration 2026-12-31
Marketing Start 2018-05-29

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 16714834
Hyphenated Format 16714-834

Supplemental Identifiers

RxCUI
1728055
UPC
0316714834016
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 ANDA201533 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • .05 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (16714-834-01) / 5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

16714-834-01 1 VIAL, SINGLE-USE in 1 CARTON (16714-834-01) / 5 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

palonosetron hydrochloride (.05 mg/mL)

Linked Drug Pages (1)

Palonosetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8d32d892-2cbb-f22e-0084-b405875974af", "openfda": {"upc": ["0316714834016"], "unii": ["23310D4I19"], "rxcui": ["1728055"], "spl_set_id": ["689c953c-2120-2546-67a4-22bb34ba3330"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (16714-834-01)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "16714-834-01", "marketing_start_date": "20180529"}], "brand_name": "Palonosetron", "product_id": "16714-834_8d32d892-2cbb-f22e-0084-b405875974af", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "16714-834", "generic_name": "Palonosetron", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Palonosetron", "active_ingredients": [{"name": "PALONOSETRON HYDROCHLORIDE", "strength": ".05 mg/mL"}], "application_number": "ANDA201533", "marketing_category": "ANDA", "marketing_start_date": "20180529", "listing_expiration_date": "20261231"}