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 · 8

ndc11
6318725604
4 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-04)
ndc11
6318725605
5 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-05)
ndc11
6318725606
6 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-06)
ndc11
6318725610
10 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-10)
ndc11
6318725612
12 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-12)
ndc11
6318725615
15 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-15)
ndc11
6318725620
20 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-20)
ndc11
6318725630
30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (63187-256-30)

Annotations

UNII (FDA Substance ID)

4AF302ESOS

ONDANSETRON

RxCUI 26225

Orange Book

A078152

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": "63187-256_3ccb1196-6b72-478b-ba07-b05849ae83e6",
  "productndc": "63187-256",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "078152",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Jun 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Jun 27, 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": "ANDA078152",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ondansetron",
  "start_marketing_date": "20070627",
  "active_numerator_strength": "4"
}

Related drugs

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