Ondansetron

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerAtlantic Biologics Corp.

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
1785606721
60 SYRINGE in 1 CASE (17856-0672-1) / 2.5 mL in 1 SYRINGE
ndc11
1785606722
120 SYRINGE in 1 CASE (17856-0672-2) / 2.5 mL in 1 SYRINGE
ndc11
1785606723
120 SYRINGE in 1 CASE (17856-0672-3) / 2.5 mL in 1 SYRINGE
ndc11
1785606724
72 CUP, UNIT-DOSE in 1 CASE (17856-0672-4) / 5 mL in 1 CUP, UNIT-DOSE

Annotations

UNII (FDA Substance ID)

NMH84OZK2B

ONDANSETRON HYDROCHLORIDE

RxCUI 203148

Orange Book

A078776

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": "17856-0672_41d71d34-d0bc-4d2b-e063-6294a90aa350",
  "productndc": "17856-0672",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "078776",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AA",
        "strength": "EQ 4MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Nov 28, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ONDANSETRON HYDROCHLORIDE",
  "proprietary_name": "Ondansetron",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA078776",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ondansetron Hydrochloride",
  "start_marketing_date": "20071128",
  "active_numerator_strength": "4"
}

Related drugs

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