Ondansetron

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerIpca Laboratories Limited

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
8398001301
100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-013-01)
ndc11
8398001310
1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-013-10)
ndc11
8398001313
30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-013-13)
ndc11
8398001383
3 BLISTER PACK in 1 CARTON (83980-013-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

4AF302ESOS

ONDANSETRON

RxCUI 26225

Orange Book

A209389

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": "83980-013_3582cf26-d9a0-4b93-93a1-d1824e55fc19",
  "productndc": "83980-013",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "209389",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Oct 30, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Oct 30, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONDANSETRON",
  "proprietary_name": "Ondansetron",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209389",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ondansetron",
  "start_marketing_date": "20250619",
  "active_numerator_strength": "8"
}

Related drugs

Other records sharing ATC code A04AA01.

Access this data programmatically

Query Ondansetron and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs