Ondansetron Hydrochloride

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerSportpharm LLC

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
8576600600
1000 TABLET, FILM COATED in 1 BOTTLE (85766-006-00)
ndc11
8576600603
3 TABLET, FILM COATED in 1 BOTTLE (85766-006-03)
ndc11
8576600605
500 TABLET, FILM COATED in 1 BOTTLE (85766-006-05)
ndc11
8576600606
6 TABLET, FILM COATED in 1 BOTTLE (85766-006-06)
ndc11
8576600608
8 TABLET, FILM COATED in 1 BOTTLE (85766-006-08)
ndc11
8576600610
10 TABLET, FILM COATED in 1 BOTTLE (85766-006-10)
ndc11
8576600624
24 TABLET, FILM COATED in 1 BOTTLE (85766-006-24)
ndc11
8576600630
30 TABLET, FILM COATED in 1 BOTTLE (85766-006-30)
ndc11
8576600660
60 TABLET, FILM COATED in 1 BOTTLE (85766-006-60)
ndc11
8576600690
90 TABLET, FILM COATED in 1 BOTTLE (85766-006-90)

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": "85766-006_4eb20508-df76-1a2a-e063-6394a90a5f40",
  "productndc": "85766-006",
  "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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