Granisetron hydrochloride

Orange BookUNIISPLATC A04AA02

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

Identification

ManufacturerNatco Pharma Limited

CountryUS (United States)

ATC codeA04AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6385000051
10 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-1)
ndc11
6385000052
2 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-2)

Annotations

UNII (FDA Substance ID)

318F6L70J8

GRANISETRON HYDROCHLORIDE

RxCUI 142149

Orange Book

A078969

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": "ORAL",
  "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": "63850-0005_67953305-4eb0-4b00-abae-716ac25c5bf9",
  "productndc": "63850-0005",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078969",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Jun 22, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GRANISETRON HYDROCHLORIDE",
  "proprietary_name": "Granisetron hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078969",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Granisetron hydrochloride",
  "start_marketing_date": "20090622",
  "active_numerator_strength": "1"
}

Related drugs

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