Potassium Phosphates

Orange BookUNIISPL

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

Identification

ManufacturerFresenius Kabi USA, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6521905429
25 VIAL, SINGLE-DOSE in 1 TRAY (65219-054-29) / 15 mL in 1 VIAL, SINGLE-DOSE (65219-054-09)

Annotations

UNII (FDA Substance ID)

CI71S98N1Z

DIBASIC POTASSIUM PHOSPHATE

RxCUI 55018

Orange Book

N212832

APAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "CI71S98N1Z",
    "rxcui": "55018",
    "inchikey": "ZPWVASYFFYYZEW-UHFFFAOYSA-L",
    "display_name": "DIBASIC POTASSIUM PHOSPHATE",
    "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": "65219-054_935c5395-1f0b-4277-97de-8b1cf1252d1e",
  "productndc": "65219-054",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "212832",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML)",
        "product_no": "001",
        "approval_date": "Nov 26, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML)",
        "product_no": "002",
        "approval_date": "Nov 26, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 26, 2019"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML)",
        "product_no": "004",
        "approval_date": "May 9, 2025"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML)",
        "product_no": "005",
        "approval_date": "May 9, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DIBASIC POTASSIUM PHOSPHATE; MONOBASIC POTASSIUM PHOSPHATE",
  "proprietary_name": "Potassium Phosphates",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA212832",
  "marketing_category": "NDA",
  "nonproprietary_name": "Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic",
  "start_marketing_date": "20200210",
  "active_numerator_strength": "236; 224"
}

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