Ondansetron Hydrochloride

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
7133513570
5 TABLET, FILM COATED in 1 BOTTLE (71335-1357-0)
ndc11
7133513571
10 TABLET, FILM COATED in 1 BOTTLE (71335-1357-1)
ndc11
7133513572
15 TABLET, FILM COATED in 1 BOTTLE (71335-1357-2)
ndc11
7133513573
4 TABLET, FILM COATED in 1 BOTTLE (71335-1357-3)
ndc11
7133513574
3 TABLET, FILM COATED in 1 BOTTLE (71335-1357-4)
ndc11
7133513575
12 TABLET, FILM COATED in 1 BOTTLE (71335-1357-5)
ndc11
7133513576
20 TABLET, FILM COATED in 1 BOTTLE (71335-1357-6)
ndc11
7133513577
30 TABLET, FILM COATED in 1 BOTTLE (71335-1357-7)
ndc11
7133513578
60 TABLET, FILM COATED in 1 BOTTLE (71335-1357-8)
ndc11
7133513579
6 TABLET, FILM COATED in 1 BOTTLE (71335-1357-9)

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": "71335-1357_d48ed97a-a53e-4757-9712-cc4bf0acd961",
  "productndc": "71335-1357",
  "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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