Ondansetron Hydrochloride

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerA-S Medication Solutions

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
5009031780
10 TABLET, FILM COATED in 1 BOTTLE (50090-3178-0)
ndc11
5009031781
6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3178-1)
ndc11
5009031782
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3178-2)
ndc11
5009031784
3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3178-4)
ndc11
5009031785
12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3178-5)

Annotations

UNII (FDA Substance ID)

NMH84OZK2B

ONDANSETRON HYDROCHLORIDE

RxCUI 203148

Orange Book

A078539

ABAB

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": "50090-3178_f74fee7b-ae98-4fbb-84fb-23cd573e3936",
  "productndc": "50090-3178",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078539",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Jul 31, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "002",
        "approval_date": "Jul 31, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 24MG BASE",
        "product_no": "003",
        "approval_date": "Jul 31, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONDANSETRON HYDROCHLORIDE",
  "proprietary_name": "Ondansetron Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078539",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ondansetron Hydrochloride",
  "start_marketing_date": "20070731",
  "active_numerator_strength": "4"
}

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