Ondansetron Hydrochloride

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
7642091600
1000 TABLET, FILM COATED in 1 BOTTLE (76420-916-00)
ndc11
7642091603
3 TABLET, FILM COATED in 1 BOTTLE (76420-916-03)
ndc11
7642091605
500 TABLET, FILM COATED in 1 BOTTLE (76420-916-05)
ndc11
7642091610
10 TABLET, FILM COATED in 1 BOTTLE (76420-916-10)
ndc11
7642091611
10 BLISTER PACK in 1 CARTON (76420-916-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
7642091630
30 TABLET, FILM COATED in 1 BOTTLE (76420-916-30)
ndc11
7642091633
1 BLISTER PACK in 1 CARTON (76420-916-33) / 3 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
7642091660
60 TABLET, FILM COATED in 1 BOTTLE (76420-916-60)
ndc11
7642091690
90 TABLET, FILM COATED in 1 BOTTLE (76420-916-90)

Annotations

UNII (FDA Substance ID)

NMH84OZK2B

ONDANSETRON HYDROCHLORIDE

RxCUI 203148

Orange Book

A078539

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": "76420-916_2cbe06c2-92c4-f72d-e063-6294a90aede8",
  "productndc": "76420-916",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078539",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 4MG BASE",
        "product_no": "001",
        "approval_date": "Jul 31, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 8MG BASE",
        "product_no": "002",
        "approval_date": "Jul 31, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 24MG BASE",
        "product_no": "003",
        "approval_date": "Jul 31, 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": "ANDA078539",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ondansetron Hydrochloride",
  "start_marketing_date": "20070731",
  "active_numerator_strength": "8"
}

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