Potassium Chloride in Dextrose

In shortageOrange BookUNIISPLATC C03CB

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

Identification

ManufacturerICU Medical Inc.

CountryUS (United States)

ATC codeC03CB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0990790509
12 POUCH in 1 CASE (0990-7905-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

LX22YL083G

DEXTROSE MONOHYDRATE

RxCUI 1299920

Orange Book

N018371

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Dextrose Monohydrate 5% Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "LX22YL083G",
    "rxcui": "1299920",
    "inchikey": "SPFMQWBKVUQXJV-BTVCFUMJSA-N",
    "display_name": "DEXTROSE MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ff67f638-5b53-406a-962a-87773a91fc48": {
      "match": "brand_token",
      "title": "POTASSIUM CITRATE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-05-28"
    }
  },
  "productid": "0990-7905_357fc68c-2f4c-4f4c-9e26-a66ff54c59ff",
  "productndc": "0990-7905",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018371",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;149MG/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;298MG/100ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;224MG/100ML",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE",
  "shortage_reason": "Dextrose Monohydrate 5% Injection",
  "shortage_status": "current",
  "proprietary_name": "Potassium Chloride in Dextrose",
  "active_ingred_unit": "g/100mL; g/100mL",
  "application_number": "NDA018371",
  "marketing_category": "NDA",
  "nonproprietary_name": "dextrose monohydrate and potassium chloride injection, solution",
  "start_marketing_date": "20201120",
  "active_numerator_strength": "5; .149"
}

Related drugs

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