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United States · US · US:65219-151_6320e059-cc2f-48b8-8ef5-c0080c35eaca

Potassium Chloride in Dextrose and Sodium Chloride

In shortageOrange BookUNIISPLATC C03CB

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeC03CB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6521915175
    20 BAG in 1 CASE (65219-151-75) / 500 mL in 1 BAG (65219-151-00)

Annotations

UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
A212348
APAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dextrose Monohydrate 70% 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": "65219-151_6320e059-cc2f-48b8-8ef5-c0080c35eaca",
  "productndc": "65219-151",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212348",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;149MG/100ML;225MG/100ML",
        "product_no": "001",
        "approval_date": "Jul 30, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;149MG/100ML;225MG/100ML",
        "product_no": "002",
        "approval_date": "Jul 30, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE",
  "shortage_reason": "Dextrose Monohydrate 70% Injection",
  "shortage_status": "current",
  "proprietary_name": "Potassium Chloride in Dextrose and Sodium Chloride",
  "active_ingred_unit": "g/1000mL; g/1000mL; g/1000mL",
  "application_number": "ANDA212348",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE",
  "start_marketing_date": "20220902",
  "active_numerator_strength": "50; 1.49; 2.25"
}

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