Ondansetron Hydrochloride

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerPHOENIX RX LLC

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
8550910761
10 TABLET, FILM COATED in 1 BOTTLE (85509-1076-1)
ndc11
8550910762
20 TABLET, FILM COATED in 1 BOTTLE (85509-1076-2)
ndc11
8550910763
30 TABLET, FILM COATED in 1 BOTTLE (85509-1076-3)
ndc11
8550910765
15 TABLET, FILM COATED in 1 BOTTLE (85509-1076-5)
ndc11
8550910766
60 TABLET, FILM COATED in 1 BOTTLE (85509-1076-6)

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": "85509-1076_3a76c251-0d7a-e587-e063-6394a90a308c",
  "productndc": "85509-1076",
  "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": "8"
}

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