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United States · US · US:0990-7111_fb53b802-9589-46e1-b404-b51c4ac61f5b

Potassium Chloride in Lactated Ringers and Dextrose

In shortageOrange BookUNIISPLATC C03CB

Last synced from FDA National Drug Code directory (United States) on

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
    0990711109
    12 POUCH in 1 CASE (0990-7111-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
M4I0D6VV5M
CALCIUM CHLORIDE
RxCUI 221068
Orange Book
N019685
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Calcium Chloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "M4I0D6VV5M",
    "rxcui": "221068",
    "inchikey": "LLSDKQJKOVVTOJ-UHFFFAOYSA-L",
    "display_name": "CALCIUM CHLORIDE",
    "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": "0990-7111_fb53b802-9589-46e1-b404-b51c4ac61f5b",
  "productndc": "0990-7111",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019685",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "001",
        "approval_date": "Oct 17, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "002",
        "approval_date": "Oct 17, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "003",
        "approval_date": "Oct 17, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "004",
        "approval_date": "Oct 17, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "005",
        "approval_date": "Oct 17, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "006",
        "approval_date": "Oct 17, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "007",
        "approval_date": "Oct 17, 1988"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "008",
        "approval_date": "Oct 17, 1988"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CALCIUM CHLORIDE; DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
  "shortage_reason": "Calcium Chloride Injection",
  "shortage_status": "current",
  "proprietary_name": "Potassium Chloride in Lactated Ringers and Dextrose",
  "active_ingred_unit": "g/1000mL; g/1000mL; g/1000mL; g/1000mL; g/1000mL",
  "application_number": "NDA019685",
  "marketing_category": "NDA",
  "nonproprietary_name": "POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE",
  "start_marketing_date": "20191125",
  "active_numerator_strength": ".2; 50; 1.79; 6; 3.1"
}

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