IDkit HP ONE

Orange BookUNIISPLATC A09AB

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

Identification

ManufacturerMeridian Bioscience Israel Ltd

CountryUS (United States)

ATC codeA09AB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5040210013
25 BAG in 1 BOX (50402-100-13) / 1 SOLUTION in 1 BAG
ndc11
5040210014
5 BOX in 1 CASE (50402-100-14) / 1 SOLUTION in 1 BOX

Annotations

UNII (FDA Substance ID)

2968PHW8QP

CITRIC ACID MONOHYDRATE

RxCUI 221079

Orange Book

N021314

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2968PHW8QP",
    "rxcui": "221079",
    "inchikey": "YASYEJJMZJALEJ-UHFFFAOYSA-N",
    "display_name": "CITRIC ACID MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8baab7a7-5d20-46ad-9c4a-762992ef6b51": {
      "match": "brand_token",
      "title": "IDKIT HP ONE (CITRIC ACID ANHYDROUS AND 13C UREA) SOLUTION [MERIDIAN BIOSCIENCE ISRAEL LTD]",
      "spl_version": "5",
      "published_date": "2025-01-31"
    }
  },
  "productid": "50402-100_14276165-5001-4e53-a474-d7cf6931f051",
  "productndc": "50402-100",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "021314",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "4GM;75MG",
        "product_no": "001",
        "approval_date": "Dec 17, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CITRIC ACID MONOHYDRATE; UREA C-13",
  "proprietary_name": "IDkit HP ONE",
  "active_ingred_unit": "g/1; mg/1",
  "application_number": "NDA021314",
  "marketing_category": "NDA",
  "nonproprietary_name": "citric acid anhydrous and 13C urea",
  "start_marketing_date": "20091228",
  "active_numerator_strength": "4; 75"
}

Related drugs

Other records sharing ATC code A09AB.

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