Potassium Chloride in Dextrose and Sodium Chloride

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
0990799309
12 POUCH in 1 CASE (0990-7993-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG

Annotations

UNII (FDA Substance ID)

LX22YL083G

DEXTROSE MONOHYDRATE

RxCUI 1299920

Orange Book

N018362

APAPAPAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Dextrose Monohydrate 50% 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": "0990-7993_944f8598-ac1a-45af-a5b4-cdc4ea9656ca",
  "productndc": "0990-7993",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "018362",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML;224MG/100ML;450MG/100ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML;298MG/100ML;450MG/100ML",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5GM/100ML;149MG/100ML;450MG/100ML",
        "product_no": "004",
        "approval_date": "Mar 28, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML;149MG/100ML;450MG/100ML",
        "product_no": "005",
        "approval_date": "Mar 28, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5GM/100ML;224MG/100ML;450MG/100ML",
        "product_no": "006",
        "approval_date": "Mar 28, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5GM/100ML;298MG/100ML;450MG/100ML",
        "product_no": "007",
        "approval_date": "Mar 28, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5GM/100ML;74.5MG/100ML;450MG/100ML",
        "product_no": "008",
        "approval_date": "Mar 28, 1988"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML;74.5MG/100ML;450MG/100ML",
        "product_no": "009",
        "approval_date": "Jul 5, 1983"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML;149MG/100ML;450MG/100ML",
        "product_no": "010",
        "approval_date": "Jul 5, 1983"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE",
  "shortage_reason": "Dextrose Monohydrate 50% Injection",
  "shortage_status": "current",
  "proprietary_name": "Potassium Chloride in Dextrose and Sodium Chloride",
  "active_ingred_unit": "g/1000mL; g/1000mL; g/1000mL",
  "application_number": "NDA018362",
  "marketing_category": "NDA",
  "nonproprietary_name": "DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE",
  "start_marketing_date": "20200201",
  "active_numerator_strength": "50; .745; 4.5"
}

Related drugs

Other records sharing ATC code C03CB.

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