Ondansetron

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6586220804
1 BOTTLE, PLASTIC in 1 CARTON (65862-208-04) / 50 mL in 1 BOTTLE, PLASTIC
ndc11
6586220850
1 BOTTLE in 1 CARTON (65862-208-50) / 50 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

NMH84OZK2B

ONDANSETRON HYDROCHLORIDE

RxCUI 203148

Orange Book

A078776

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": "65862-208_a839599f-f788-4039-9e34-b443d1c9849b",
  "productndc": "65862-208",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "078776",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 4MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Nov 28, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONDANSETRON HYDROCHLORIDE",
  "proprietary_name": "Ondansetron",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA078776",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ondansetron Hydrochloride",
  "start_marketing_date": "20071128",
  "active_numerator_strength": "4"
}

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