Granisetron

Orange BookUNIISPLATC A04AA02

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC codeA04AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6332331801
1 VIAL, SINGLE-USE in 1 BOX (63323-318-01) / 1 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

318F6L70J8

GRANISETRON HYDROCHLORIDE

RxCUI 142149

Orange Book

A078096

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "318F6L70J8",
    "rxcui": "142149",
    "inchikey": "QYZRTBKYBJRGJB-WQTKJZBYSA-N",
    "display_name": "GRANISETRON HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "8d88adba-7f5e-4e97-84b3-6ca8ec98c023": {
      "match": "brand_token",
      "title": "GRANISETRON HYDROCHLORIDE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC]",
      "spl_version": "4",
      "published_date": "2026-01-12"
    }
  },
  "productid": "63323-318_fd73c3f4-aa7d-4c2f-ab74-1883910ea086",
  "productndc": "63323-318",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "078096",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/ML (EQ 1MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Jun 30, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GRANISETRON HYDROCHLORIDE",
  "proprietary_name": "Granisetron",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078096",
  "marketing_category": "ANDA",
  "nonproprietary_name": "GRANISETRON HYDROCHLORIDE",
  "start_marketing_date": "20091120",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A04AA02.

Access this data programmatically

Query Granisetron and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs