ondansetron hydrochloride

Orange BookUNIISPLATC A04AA01

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

Identification

ManufacturerDr. Reddy's Laboratories Limited

CountryUS (United States)

ATC codeA04AA01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5511115505
500 TABLET, FILM COATED in 1 BOTTLE (55111-155-05)
ndc11
5511115530
30 TABLET, FILM COATED in 1 BOTTLE (55111-155-30)
ndc11
5511115578
10 BLISTER PACK in 1 CARTON (55111-155-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-155-79)

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": "55111-155_9064dccd-0ae4-688a-3216-6ced5e514340",
  "productndc": "55111-155",
  "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": "16"
}

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