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United States · US · US:0338-0704_0770d1c7-920a-4569-9e1d-de264bea58b1

Potassium Chloride in Sodium Chloride

In shortageOrange BookUNIISPLATC C03CB

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

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
    0338070434
    14 BAG in 1 CARTON (0338-0704-34) / 1000 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
660YQ98I10
POTASSIUM CHLORIDE
RxCUI 8591
Orange Book
N017648
APAPAP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Potassium Citrate Tablet, Extended Release
Raw payload (JSON)
{
  "unii": {
    "unii": "660YQ98I10",
    "rxcui": "8591",
    "inchikey": "WCUXLLCKKVVCTQ-UHFFFAOYSA-M",
    "display_name": "POTASSIUM CHLORIDE",
    "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": "0338-0704_0770d1c7-920a-4569-9e1d-de264bea58b1",
  "productndc": "0338-0704",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "017648",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "150MG/100ML;900MG/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "300MG/100ML;900MG/100ML",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "224MG/100ML;900MG/100ML",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "75MG/100ML;900MG/100ML",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "150MG/100ML;450MG/100ML",
        "product_no": "005",
        "approval_date": "Nov 26, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "POTASSIUM CHLORIDE; SODIUM CHLORIDE",
  "shortage_reason": "Potassium Citrate Tablet, Extended Release",
  "shortage_status": "current",
  "proprietary_name": "Potassium Chloride in Sodium Chloride",
  "active_ingred_unit": "mg/100mL; mg/100mL",
  "application_number": "NDA017648",
  "marketing_category": "NDA",
  "nonproprietary_name": "Potassium Chloride and Sodium Chloride",
  "start_marketing_date": "19790202",
  "active_numerator_strength": "150; 450"
}

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