Ondansetron

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerATLANTIC BIOLOGICALS CORP.

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
1785606911
1.5 mL in 1 SYRINGE (17856-0691-1)
ndc11
1785606912
2.5 mL in 1 SYRINGE, PLASTIC (17856-0691-2)
ndc11
1785606914
2.5 mL in 1 SYRINGE, PLASTIC (17856-0691-4)
ndc11
1785606915
5 mL in 1 CUP (17856-0691-5)
ndc11
1785606916
120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-6) / 1.25 mL in 1 SYRINGE
ndc11
1785606917
48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-7) / 1.9 mL in 1 SYRINGE
ndc11
1785606918
60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-8) / 2.5 mL in 1 SYRINGE

Annotations

UNII (FDA Substance ID)

NMH84OZK2B

ONDANSETRON HYDROCHLORIDE

RxCUI 203148

Orange Book

A091483

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": "17856-0691_3633ef65-d53d-4728-e063-6394a90a6205",
  "productndc": "17856-0691",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "091483",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 4MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Jan 31, 2011"
      }
    ],
    "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": "ANDA091483",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ondansetron",
  "start_marketing_date": "20101217",
  "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