Potassium Chloride in Lactated Ringers and Dextrose

In shortageOrange BookUNIISPLATC C03CB

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

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC codeC03CB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338081104
1000 mL in 1 BAG (0338-0811-04)

Annotations

UNII (FDA Substance ID)

M4I0D6VV5M

CALCIUM CHLORIDE

RxCUI 221068

Orange Book

N019367

APAPAPAPAP

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": "0338-0811_127c3c05-ab6d-4c6c-84f9-9552f450f58b",
  "productndc": "0338-0811",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019367",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "001",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/100ML;5GM/100ML;105MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "002",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "003",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "004",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "005",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "006",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "007",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "20MG/100ML;5GM/100ML;328MG/100ML;600MG/100ML;310MG/100ML",
        "product_no": "008",
        "approval_date": "Apr 5, 1985"
      }
    ],
    "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": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
  "application_number": "NDA019367",
  "marketing_category": "NDA",
  "nonproprietary_name": "DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE",
  "start_marketing_date": "19850405",
  "active_numerator_strength": "20; 5; 179; 600; 310"
}

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