ondansetron hydrochloride

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6275613001
30 TABLET, FILM COATED in 1 BOTTLE (62756-130-01)
ndc11
6275613002
10 BLISTER PACK in 1 DOSE PACK (62756-130-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

NMH84OZK2B

ONDANSETRON HYDROCHLORIDE

RxCUI 203148

Orange Book

A077050

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": "62756-130_e83d90db-54a7-4c13-bd68-b1620a8aecaf",
  "productndc": "62756-130",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077050",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Jun 25, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "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 hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077050",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ondansetron hydrochloride",
  "start_marketing_date": "20070625",
  "active_numerator_strength": "4"
}

Related drugs

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