Potassium Chloride in Dextrose

In shortageOrange BookUNIISPLATC C03CB

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

Identification

ManufacturerBaxter Healthcare Company

CountryUS (United States)

ATC codeC03CB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338068304
1000 mL in 1 BAG (0338-0683-04)

Annotations

UNII (FDA Substance ID)

LX22YL083G

DEXTROSE MONOHYDRATE

RxCUI 1299920

Orange Book

N017634

APAPAP

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": "0338-0683_b312752a-f970-43c1-96de-eccf5a461e88",
  "productndc": "0338-0683",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "017634",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML;150MG/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML;300MG/100ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5GM/100ML;224MG/100ML",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML;75MG/100ML",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE",
  "shortage_reason": "Dextrose Monohydrate 50% Injection",
  "shortage_status": "current",
  "proprietary_name": "Potassium Chloride in Dextrose",
  "active_ingred_unit": "g/100mL; mg/100mL",
  "application_number": "NDA017634",
  "marketing_category": "NDA",
  "nonproprietary_name": "Potassium Chloride and Dextrose Monohydrate",
  "start_marketing_date": "19790201",
  "active_numerator_strength": "5; 150"
}

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