Granisetron Hydrochloride

Orange BookUNIISPLATC A04AA02

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

Identification

ManufacturerBionpharma Inc.

CountryUS (United States)

ATC codeA04AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
6945235001
2 BLISTER PACK in 1 CARTON (69452-350-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
6945235011
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-350-11)
ndc11
6945235092
2 BLISTER PACK in 1 CARTON (69452-350-92) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

318F6L70J8

GRANISETRON HYDROCHLORIDE

RxCUI 142149

Orange Book

A078678

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": "69452-350_cfe3b317-aba5-46b3-83fd-df5a6d71ea76",
  "productndc": "69452-350",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078678",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 1MG BASE",
        "product_no": "001",
        "approval_date": "Feb 13, 2008"
      }
    ],
    "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": "ANDA078678",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Granisetron Hydrochloride",
  "start_marketing_date": "20220228",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code A04AA02.

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