Ondansetron

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
7133510710
3 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-1071-0)
ndc11
7133510711
30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-1071-1)
ndc11
7133510712
10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-1071-2)
ndc11
7133510713
5 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-1071-3)
ndc11
7133510714
4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-1071-4)
ndc11
7133510715
6 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-1071-5)
ndc11
7133510716
14 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-1071-6)
ndc11
7133510717
60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-1071-7)
ndc11
7133510718
12 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-1071-8)
ndc11
7133510719
90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-1071-9)

Annotations

UNII (FDA Substance ID)

4AF302ESOS

ONDANSETRON

RxCUI 26225

Orange Book

A090469

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "4AF302ESOS",
    "rxcui": "26225",
    "inchikey": "FELGMEQIXOGIFQ-UHFFFAOYSA-N",
    "display_name": "ONDANSETRON",
    "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": "71335-1071_1f46e4a9-ad67-4deb-9c21-e3b2452a16ea",
  "productndc": "71335-1071",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "090469",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Apr 12, 2010"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Apr 12, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONDANSETRON",
  "proprietary_name": "Ondansetron",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090469",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ondansetron",
  "start_marketing_date": "20100412",
  "active_numerator_strength": "8"
}

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