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

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
6521914210
10 BAG in 1 CASE (65219-142-10) / 1000 mL in 1 BAG (65219-142-02)

Annotations

UNII (FDA Substance ID)

LX22YL083G

DEXTROSE MONOHYDRATE

RxCUI 1299920

Orange Book

A213523

APAPAPAPAP

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": "65219-142_93737cd2-f9e0-41e1-9263-2c4ff516395a",
  "productndc": "65219-142",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "213523",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;74.5MG/100ML;450MG/100ML",
        "product_no": "001",
        "approval_date": "Mar 9, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;149MG/100ML;450MG/100ML",
        "product_no": "002",
        "approval_date": "Mar 9, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;224MG/100ML;450MG/100ML",
        "product_no": "003",
        "approval_date": "Mar 9, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;298MG/100ML;450MG/100ML",
        "product_no": "004",
        "approval_date": "Mar 9, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;149MG/100ML;450MG/100ML",
        "product_no": "005",
        "approval_date": "Oct 11, 2022"
      }
    ],
    "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": "ANDA213523",
  "marketing_category": "ANDA",
  "nonproprietary_name": "DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, and POTASSIUM CHLORIDE",
  "start_marketing_date": "20220826",
  "active_numerator_strength": "50; .745; 4.5"
}

Related drugs

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