Palonosetron Hydrochloride

In shortageOrange BookUNIISPLATC A04AA55

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAvenacy, Inc.

CountryUS (United States)

ATC codeA04AA55

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8363477705
1 VIAL, SINGLE-DOSE in 1 CARTON (83634-777-05) / 5 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

23310D4I19

PALONOSETRON HYDROCHLORIDE

RxCUI 397405

Orange Book

A202951

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Palonosetron Hydrochloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "23310D4I19",
    "rxcui": "397405",
    "inchikey": "OLDRWYVIKMSFFB-SSPJITILSA-N",
    "display_name": "PALONOSETRON HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "911783eb-91a8-4ef4-bd6f-809211e207d6": {
      "match": "brand_token",
      "title": "PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.]",
      "spl_version": "9",
      "published_date": "2026-03-30"
    }
  },
  "productid": "83634-777_2b7c65dc-88e9-4e1d-8751-43ff4878d913",
  "productndc": "83634-777",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "202951",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jun 29, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Jun 29, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PALONOSETRON HYDROCHLORIDE",
  "shortage_reason": "Palonosetron Hydrochloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Palonosetron Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA202951",
  "marketing_category": "ANDA",
  "nonproprietary_name": "palonosetron hydrochloride",
  "start_marketing_date": "20240515",
  "active_numerator_strength": ".05"
}

Related drugs

Other records sharing ATC code A04AA55.

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