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United States · US · US:63323-667_fa0a4b99-d041-42d8-843d-e7dbead01d89

Potassium 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
    6332366710
    10 BAG in 1 CASE (63323-667-10) / 1000 mL in 1 BAG (63323-667-01)

Annotations

UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
A212346
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": "63323-667_fa0a4b99-d041-42d8-843d-e7dbead01d89",
  "productndc": "63323-667",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212346",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;75MG/100ML",
        "product_no": "001",
        "approval_date": "Sep 10, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "5GM/100ML;150MG/100ML",
        "product_no": "002",
        "approval_date": "Sep 10, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE; POTASSIUM CHLORIDE",
  "shortage_reason": "Dextrose Monohydrate 70% Injection",
  "shortage_status": "current",
  "proprietary_name": "Potassium Chloride",
  "active_ingred_unit": "g/100mL; mg/100mL",
  "application_number": "ANDA212346",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Potassium Chloride, Dextrose Monohydrate",
  "start_marketing_date": "20210423",
  "active_numerator_strength": "5; 75"
}

Related drugs

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