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United States · US · US:71335-2974_9ffcf3b8-959a-41c9-b9df-f96ea5311b44

Ondansetron

Orange BookUNIISPLATC A04AA01

Last synced from FDA National Drug Code directory (United States) on

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
    7133529740
    14 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2974-0)
  • ndc11
    7133529741
    30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2974-1)
  • ndc11
    7133529742
    10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2974-2)
  • ndc11
    7133529743
    9 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2974-3)
  • ndc11
    7133529744
    5 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2974-4)
  • ndc11
    7133529745
    3 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2974-5)
  • ndc11
    7133529746
    6 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2974-6)
  • ndc11
    7133529747
    12 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2974-7)
  • ndc11
    7133529748
    4 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2974-8)
  • ndc11
    7133529749
    20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2974-9)

Annotations

UNII (FDA Substance ID)
4AF302ESOS
ONDANSETRON
RxCUI 26225
Orange Book
A209389
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": "71335-2974_9ffcf3b8-959a-41c9-b9df-f96ea5311b44",
  "productndc": "71335-2974",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING",
  "orange_book": {
    "appl_no": "209389",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "4MG",
        "product_no": "001",
        "approval_date": "Oct 30, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "8MG",
        "product_no": "002",
        "approval_date": "Oct 30, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONDANSETRON",
  "proprietary_name": "Ondansetron",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209389",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ondansetron",
  "start_marketing_date": "20250619",
  "active_numerator_strength": "8"
}

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