ONDANSETRON

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5009049350
25 VIAL, SINGLE-USE in 1 CARTON (50090-4935-0) / 2 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

NMH84OZK2B

ONDANSETRON HYDROCHLORIDE

RxCUI 203148

Orange Book

A203711

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "NMH84OZK2B",
    "rxcui": "203148",
    "inchikey": "VRSLTNZJOUZKLX-UHFFFAOYSA-N",
    "display_name": "ONDANSETRON HYDROCHLORIDE",
    "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": "50090-4935_939b693c-3eb0-406b-abd1-b3fe055cfe35",
  "productndc": "50090-4935",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "203711",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 2MG BASE/ML",
        "product_no": "001",
        "approval_date": "Sep 8, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONDANSETRON HYDROCHLORIDE",
  "proprietary_name": "ONDANSETRON",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA203711",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ONDANSETRON",
  "start_marketing_date": "20160526",
  "active_numerator_strength": "2"
}

Related drugs

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