ondansetron

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerAccord Healthcare, Inc.

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1672929805
20 mL in 1 VIAL (16729-298-05)

Annotations

UNII (FDA Substance ID)

4AF302ESOS

ONDANSETRON

RxCUI 26225

Orange Book

A206846

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4AF302ESOS",
    "rxcui": "26225",
    "inchikey": "FELGMEQIXOGIFQ-UHFFFAOYSA-N",
    "display_name": "ONDANSETRON",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "d62cd60b-f87e-4825-bead-1d18bbc4e480": {
      "match": "brand_token",
      "title": "ONDANSETRON INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "4",
      "published_date": "2026-05-25"
    }
  },
  "productid": "16729-298_424e0911-305e-8eb5-e063-6294a90aaab3",
  "productndc": "16729-298",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "206846",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2MG BASE/ML",
        "product_no": "001",
        "approval_date": "Jul 13, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONDANSETRON",
  "proprietary_name": "ondansetron",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA206846",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ondansetron",
  "start_marketing_date": "20161020",
  "active_numerator_strength": "2"
}

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