Granisetron Hydrochloride

Orange BookUNIISPLATC A04AA02

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeA04AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0143974410
10 VIAL, SINGLE-USE in 1 PACKAGE (0143-9744-10) / 1 mL in 1 VIAL, SINGLE-USE (0143-9744-01)

Annotations

UNII (FDA Substance ID)

318F6L70J8

GRANISETRON HYDROCHLORIDE

RxCUI 142149

Orange Book

A078629

APAP

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": "0143-9744_3b366664-32e3-4d5c-b75c-0b764ffa31f6",
  "productndc": "0143-9744",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "078629",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1MG BASE/ML (EQ 1MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Dec 23, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 4MG BASE/4ML (EQ 1MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Dec 23, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GRANISETRON HYDROCHLORIDE",
  "proprietary_name": "Granisetron Hydrochloride",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078629",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Granisetron Hydrochloride",
  "start_marketing_date": "20091223",
  "active_numerator_strength": "1"
}

Related drugs

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