SUSTOL

Orange BookUNIISPLATC A04AA02

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

Identification

ManufacturerHeron Therapeutics, Inc.

CountryUS (United States)

ATC codeA04AA02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4742610106
6 KIT in 1 CARTON (47426-101-06) / 1 SYRINGE, GLASS in 1 KIT / .4 mL in 1 SYRINGE, GLASS

Annotations

UNII (FDA Substance ID)

WZG3J2MCOL

GRANISETRON

RxCUI 26237

Orange Book

N022445

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "WZG3J2MCOL",
    "rxcui": "26237",
    "inchikey": "MFWNKCLOYSRHCJ-BTTYYORXSA-N",
    "display_name": "GRANISETRON",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "SUBCUTANEOUS",
  "spl_meta": {
    "f7c7ffdd-8270-4030-bc1e-a1cb28a6de56": {
      "match": "brand_token",
      "title": "SUSTOL (GRANISETRON) INJECTION [HERON THERAPEUTICS, INC.]",
      "spl_version": "10",
      "published_date": "2026-03-02"
    }
  },
  "productid": "47426-101_d4d4e836-ebba-4666-b6da-9d5a846dfcf8",
  "productndc": "47426-101",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "022445",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG/0.4ML (10MG/0.4ML)",
        "product_no": "001",
        "approval_date": "Aug 9, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GRANISETRON",
  "proprietary_name": "SUSTOL",
  "active_ingred_unit": "mg/.4mL",
  "application_number": "NDA022445",
  "marketing_category": "NDA",
  "nonproprietary_name": "granisetron",
  "start_marketing_date": "20160809",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code A04AA02.

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