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

ManufacturerBaxter Healthcare Company

CountryUS (United States)

ATC codeC03CB

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338080704
1000 mL in 1 BAG (0338-0807-04)

Annotations

UNII (FDA Substance ID)

LX22YL083G

DEXTROSE MONOHYDRATE

RxCUI 1299920

Orange Book

N019308

APAP

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Dextrose Monohydrate 5% 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": "0338-0807_34c74d23-f49a-4e1c-9ffe-9a200d0fffe7",
  "productndc": "0338-0807",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "019308",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;150MG/100ML;900MG/100ML",
        "product_no": "001",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;150MG/100ML;900MG/100ML",
        "product_no": "002",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;300MG/100ML;900MG/100ML",
        "product_no": "003",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;75MG/100ML;900MG/100ML",
        "product_no": "004",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;150MG/100ML;900MG/100ML",
        "product_no": "005",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;224MG/100ML;900MG/100ML",
        "product_no": "006",
        "approval_date": "Apr 5, 1985"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;300MG/100ML;900MG/100ML",
        "product_no": "007",
        "approval_date": "Apr 5, 1985"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE; SODIUM CHLORIDE",
  "shortage_reason": "Dextrose Monohydrate 5% Injection",
  "shortage_status": "current",
  "proprietary_name": "Potassium Chloride in Dextrose and Sodium Chloride",
  "active_ingred_unit": "g/100mL; mg/100mL; mg/100mL",
  "application_number": "NDA019308",
  "marketing_category": "NDA",
  "nonproprietary_name": "Potassium Chloride, Dextrose Monohydrate and Sodium Chloride",
  "start_marketing_date": "19850405",
  "active_numerator_strength": "5; 300; 900"
}

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