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 · 9

ndc11
6318752603
3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-03)
ndc11
6318752604
4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-04)
ndc11
6318752605
5 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-05)
ndc11
6318752606
6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-06)
ndc11
6318752610
10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-10)
ndc11
6318752612
12 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63187-526-12)
ndc11
6318752615
15 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-15)
ndc11
6318752620
20 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-20)
ndc11
6318752630
30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (63187-526-30)

Annotations

UNII (FDA Substance ID)

4AF302ESOS

ONDANSETRON

RxCUI 26225

Orange Book

A090469

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": "63187-526_0507d498-219e-4f9d-b92e-f6fd15657b5a",
  "productndc": "63187-526",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "090469",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Apr 12, 2010"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Apr 12, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONDANSETRON",
  "proprietary_name": "Ondansetron",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090469",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ondansetron",
  "start_marketing_date": "20100412",
  "active_numerator_strength": "4"
}

Related drugs

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