Ondansetron Hydrochloride

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0054006447
1 BOTTLE, GLASS in 1 CARTON (0054-0064-47) / 50 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)

NMH84OZK2B

ONDANSETRON HYDROCHLORIDE

RxCUI 203148

Orange Book

A076960

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": "ORAL",
  "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": "0054-0064_64864cbd-055c-436b-80cc-a65e6ac6b02d",
  "productndc": "0054-0064",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "076960",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 4MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Dec 26, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONDANSETRON HYDROCHLORIDE",
  "proprietary_name": "Ondansetron Hydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA076960",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ondansetron Hydrochloride",
  "start_marketing_date": "20061226",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code A04AA01.

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