Granisol

Orange BookUNIISPLATC A04AA02

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

Identification

ManufacturerIntra-Sana Laboratories

CountryUS (United States)

ATC codeA04AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8005680130
30 mL in 1 BOTTLE, GLASS (80056-801-30)

Annotations

UNII (FDA Substance ID)

318F6L70J8

GRANISETRON HYDROCHLORIDE

RxCUI 142149

Orange Book

A219282

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": {
    "2758eb4d-2fe0-4f74-b3f5-b4903009e97c": {
      "match": "brand_token",
      "title": "GRANISOL (GRANISETRON HYDROCHLORIDE) SOLUTION [INTRA-SANA LABORATORIES]",
      "spl_version": "2",
      "published_date": "2025-07-07"
    }
  },
  "productid": "80056-801_30daad07-468f-c766-e063-6294a90a0019",
  "productndc": "80056-801",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "219282",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE/10ML",
        "product_no": "001",
        "approval_date": "Mar 17, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GRANISETRON HYDROCHLORIDE",
  "proprietary_name": "Granisol",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA219282",
  "marketing_category": "ANDA",
  "nonproprietary_name": "granisetron hydrochloride",
  "start_marketing_date": "20250704",
  "active_numerator_strength": "2"
}

Related drugs

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