ONDANSETRON

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6318767010
10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-670-10)
ndc11
6318767015
15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-670-15)
ndc11
6318767020
20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-670-20)
ndc11
6318767030
30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-670-30)

Annotations

UNII (FDA Substance ID)

4AF302ESOS

ONDANSETRON

RxCUI 26225

Orange Book

A077557

ABAB

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": "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": "63187-670_f302f985-2fc7-4ba8-bcc5-4ff5e4e127dd",
  "productndc": "63187-670",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "077557",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Aug 2, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Aug 2, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONDANSETRON",
  "proprietary_name": "ONDANSETRON",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077557",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ONDANSETRON",
  "start_marketing_date": "20070802",
  "active_numerator_strength": "4"
}

Related drugs

Other records sharing ATC code A04AA01.

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