ondansetron hydrochloride

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
0615818500
5 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-00)
ndc11
0615818505
15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-05)
ndc11
0615818510
10 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-10)
ndc11
0615818512
12 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-12)
ndc11
0615818539
30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8185-39)

Annotations

UNII (FDA Substance ID)

NMH84OZK2B

ONDANSETRON HYDROCHLORIDE

RxCUI 203148

Orange Book

A076183

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": "0615-8185_cb0b89ea-904e-424e-9213-80fc4d073fe3",
  "productndc": "0615-8185",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "076183",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 24MG BASE",
        "product_no": "001",
        "approval_date": "Dec 26, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "002",
        "approval_date": "Dec 26, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "003",
        "approval_date": "Dec 26, 2006"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 16MG BASE",
        "product_no": "004",
        "approval_date": "Dec 26, 2006"
      }
    ],
    "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": "ANDA076183",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ondansetron hydrochloride",
  "start_marketing_date": "20061226",
  "active_numerator_strength": "4"
}

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