Granisetron Hydrochloride

Orange BookUNIISPLATC A04AA02

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

Identification

ManufacturerBreckenridge Pharmaceutical, Inc.

CountryUS (United States)

ATC codeA04AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5199173520
2 BLISTER PACK in 1 CARTON (51991-735-20) / 10 TABLET in 1 BLISTER PACK
ndc11
5199173532
1 BLISTER PACK in 1 CARTON (51991-735-32) / 2 TABLET in 1 BLISTER PACK

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": "51991-735_1919cca7-47e5-4474-8ad1-a49275d4f85b",
  "productndc": "51991-735",
  "dosage_form": "TABLET",
  "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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