ONDANSETRON

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
6318706510
10 TABLET, FILM COATED in 1 BOTTLE (63187-065-10)
ndc11
6318706515
15 TABLET, FILM COATED in 1 BOTTLE (63187-065-15)
ndc11
6318706520
20 TABLET, FILM COATED in 1 BOTTLE (63187-065-20)
ndc11
6318706530
30 TABLET, FILM COATED in 1 BOTTLE (63187-065-30)
ndc11
6318706560
60 TABLET, FILM COATED in 1 BOTTLE (63187-065-60)
ndc11
6318706590
90 TABLET, FILM COATED in 1 BOTTLE (63187-065-90)

Annotations

UNII (FDA Substance ID)

NMH84OZK2B

ONDANSETRON HYDROCHLORIDE

RxCUI 203148

Orange Book

A077851

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": "63187-065_dcd5d6d3-2419-467f-91c2-50586e9ca5cb",
  "productndc": "63187-065",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077851",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Jun 25, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "002",
        "approval_date": "Jun 25, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONDANSETRON HYDROCHLORIDE",
  "proprietary_name": "ONDANSETRON",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077851",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ONDANSETRON",
  "start_marketing_date": "20070625",
  "active_numerator_strength": "8"
}

Related drugs

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