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
7642091500
1000 TABLET, FILM COATED in 1 BOTTLE (76420-915-00)
ndc11
7642091503
3 TABLET, FILM COATED in 1 BOTTLE (76420-915-03)
ndc11
7642091505
500 TABLET, FILM COATED in 1 BOTTLE (76420-915-05)
ndc11
7642091510
10 TABLET, FILM COATED in 1 BOTTLE (76420-915-10)
ndc11
7642091511
10 BLISTER PACK in 1 CARTON (76420-915-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
7642091530
30 TABLET, FILM COATED in 1 BOTTLE (76420-915-30)
ndc11
7642091533
1 BLISTER PACK in 1 CARTON (76420-915-33) / 3 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
7642091560
60 TABLET, FILM COATED in 1 BOTTLE (76420-915-60)
ndc11
7642091590
90 TABLET, FILM COATED in 1 BOTTLE (76420-915-90)

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": "76420-915_2cbe06c2-92c4-f72d-e063-6294a90aede8",
  "productndc": "76420-915",
  "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": "4"
}

Related drugs

Other records sharing ATC code A04AA01.

Access this data programmatically

Query Ondansetron Hydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs