palonosetron

Generic: palonosetron

Labeler: dr.reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name palonosetron
Generic Name palonosetron
Labeler dr.reddy's laboratories limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

palonosetron hydrochloride .05 mg/mL

Manufacturer
Dr.Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-694
Product ID 55111-694_7b1217ad-b626-0b2b-88d8-ae44fa91dbbd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201533
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 55111694
Hyphenated Format 55111-694

Supplemental Identifiers

RxCUI
1728050 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 (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 (55111-694-07) / 5 mL in 1 VIAL, SINGLE-USE
  • 5 VIAL, SINGLE-USE in 1 CARTON (55111-694-19) / 1.5 mL in 1 VIAL, SINGLE-USE (55111-694-15)
source: ndc

Packages (2)

55111-694-07 1 VIAL, SINGLE-USE in 1 CARTON (55111-694-07) / 5 mL in 1 VIAL, SINGLE-USE 55111-694-19 5 VIAL, SINGLE-USE in 1 CARTON (55111-694-19) / 1.5 mL in 1 VIAL, SINGLE-USE (55111-694-15)

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": "7b1217ad-b626-0b2b-88d8-ae44fa91dbbd", "openfda": {"unii": ["23310D4I19"], "rxcui": ["1728050", "1728055"], "spl_set_id": ["991b8452-852c-c55c-7b1b-e97c4964777a"], "manufacturer_name": ["Dr.Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (55111-694-07)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "55111-694-07", "marketing_start_date": "20180323"}, {"sample": false, "description": "5 VIAL, SINGLE-USE in 1 CARTON (55111-694-19)  / 1.5 mL in 1 VIAL, SINGLE-USE (55111-694-15)", "package_ndc": "55111-694-19", "marketing_start_date": "20180323"}], "brand_name": "Palonosetron", "product_id": "55111-694_7b1217ad-b626-0b2b-88d8-ae44fa91dbbd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "55111-694", "generic_name": "Palonosetron", "labeler_name": "Dr.Reddy's Laboratories Limited", "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": "20180323", "listing_expiration_date": "20261231"}