Potassium Chloride in 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
6332368310
10 BAG in 1 CARTON (63323-683-10) / 1000 mL in 1 BAG (63323-683-01)

Annotations

UNII (FDA Substance ID)

660YQ98I10

POTASSIUM CHLORIDE

RxCUI 8591

Orange Book

A212347

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": "63323-683_23c084c3-6c81-4691-9e86-0c2a17df7076",
  "productndc": "63323-683",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "212347",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "150MG/100ML;450MG/100ML",
        "product_no": "001",
        "approval_date": "Sep 17, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "300MG/100ML;900MG/100ML",
        "product_no": "002",
        "approval_date": "Sep 17, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "150MG/100ML;900MG/100ML",
        "product_no": "003",
        "approval_date": "Jun 2, 2021"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA212347",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Sodium Chloride and Potassium Chloride",
  "start_marketing_date": "20210602",
  "active_numerator_strength": "150; 450"
}

Related drugs

Other records sharing ATC code C03CB.

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